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MSDS Material Safety Data Sheet
CAS

9002-88-4
24937-78-8
26221-73-8
9003-07-0

File Name: us_coloplast_com---assura_ac_90mm_msds.asp
Material Safety Data Sheet (MSDS)
Assura庐 AC 3 1/2鈥? (90mm) 鈥? Baseplate, Standard Wear

MATERIAL SAFETY DATA SHEET:
Reference: This MSDS is prepared to comply with: 29 CFR 1910.1200; Directive 91/155/EEC.

SECTION 1. - - - - - - - - - - IDENTIFICATION OF PRODUCT AND COMPANY - - - - - - - - - -


PRODUCT NAME Assura庐 Adhesive Coupling Baseplate 90 mm
PRODUCT CODE 14309
Product Information: Ostomy

Manufacturer: Coloplast A/S
Holtedam 1
DK-3050 Humleb忙k
Denmark
Telephone: +45 49 11 11 11 Fax: +45 49 11 22 60


SECTION 2. - - - - - - - - - COMPOSITION / INFORMATION ON INGREDIENTS - - - - - - - - - - -

This product does not contain substances classified as hazardous under EC nor US OSHA regulations.
Main ingredients and packaging materials are listed below.

EC-No.
Chemical Name CAS -No.

Ostomy Pouch:
PE (polyethylene) 9002-88-4
EVA (ethylenevinylacetate) 24937-78-8
Ethylene-octene copolymer 26221-73-8
PP (polypropylene) 9003-07-0
Adhesive
Siliconized film
Cardboard

Packaging:
Corrugated cardboard




SECTION 3. - - - - - - - - - - HAZARDS IDENTIFICATION - - - - - - - - - -


This product consists primarily of polymer materials. Products poses no immediate hazard, but can give
rise to toxic fumes in a fire.

SECTION 4. - - - - - - - - - - FIRST-AID MEASURES - - - - - - - - - -

In Case of Eye Contact: Not relevant
In Case of Skin Contact: This product is intended to be in contact with the skin when used as directed
in the instructions for use
If Inhaled: Not relevant
If Ingested/Swallowed: Not relevant
Other: Show this Safety Data Sheet to a physician or emergency ward.

SECTION 5. - - - - - - - - - - FIRE FIGHTING MEASURES - - - - - - - - - -

Extinguishing Media: Use water spray, carbon dioxide, dry chemical powder or appropriate foam.
Special Firefighting Procedures: Keep personnel removed from and upwind of fire. Wear full fire
fighting turnout gear and respiratory protection.
Exposure Hazard: Smoke, soot, CO/CO2, and other toxic fumes. Avoid contact with heated or molten
product. Do not breathe vapors from heated product.


SECTION 6. - - - - - - - - - - ACCIDENTAL RELEASE MEASURES - - - - - - - - - -

No specific measures

SECTION 7. - - - - - - - - - - HANDLING AND STORAGE - - - - - - - - - -

Handling: See instructions for use.
Storage: Store until use as supplied and at normal temperatures


SECTION 8. - - - - - - - - - - EXPOSURE CONTROLS / PERSONAL PROTECTION - - - - - - - - - -

Engineering Measures: None required
Personal Protective Measures: None required
Exposure limit values: None


SECTION 9. - - - - - - - - - - PHYSICAL AND CHEMICAL PROPERTIES - - - - - - - - - -

Appearance:
Odor: None
Physical State: Solid
pH: Not applicable
Vapor Pressure: Not applicable
Vapor Density: Not applicable
Boiling Point: Not applicable
Melting Point/Freezing Point: Not applicable
Solubility: Not applicable
Density: Not applicable
Flash Point: Unknown


SECTION 10. - - - - - - - - - - STABILITY AND REACTIVITY - - - - - - - - - -

Stability: The product is stable under ambient conditions
Conditions to avoid: High temperatures
Materials to avoid: None known
Hazardous Decomposition Products: Heating may produce toxic fumes
Hazardous polymerization: No
SECTION 11. - - - - - - - - - - TOXICOLOGICAL INFORMATION - - - - - - - - - -

This product is a medical device and has been evaluated according to the requirements of medical
devices. According to current knowledge this product is considered non-toxic.

For further information please contact Coloplast A/S at the telephone number found in section 1.

SECTION 12. - - - - - - - - - - ECOLOGICAL INFORMATION - - - - - - - - - -

Ecotoxicological data have not been determined specifically for this product. Based on toxicity data on
the ingredients no ecotoxicological effects are expected. However, the product is not biodegradable and
discharge to the environment should be avoided.

For further information please contact Coloplast A/S at the telephone number found in section 1.

SECTION 13. - - - - - - - - - - DISPOSAL CONSIDERATIONS - - - - - - - - - -

The recommended disposal technology is incineration at any approved facility. The disposal should
always be in compliance with National, Federal, State and local regulations. The product should not be
discharged to the environment.

US: If this product as supplied becomes a waste, is does not meet the criteria of a hazardous waste as
defined under the Ressource Conservation and Recovery Act (RCRA) 40 CFR 261.

European Union: Per The European Waste Catalogue (EWC), in accordance with EC Directive
75/442/EEC, the following Waste Code can be used: 18 01 04 00 wastes whose collection and disposal is
not subject to special requirements in view of the prevention of infection (e.g. dressings, plaster casts,
linen, disposable clothing, diapers). However, if the waste in view of the prevention of infection needs
special requirements, other Waste Codes should be used. It is the responsibility of the holder of the waste
to determine the actual classification. Waste from private household may be disposed of together with
other household waste.

SECTION 14. - - - - - - - - - - TRANSPORT INFORMATION - - - - - - - - - -

Not dangerous goods (ADR 2003, RID, DOT).

SECTION 15. - - - - - - - - - - - REGULATORY INFORMATION - - - - - - - - - -

United States: This product is regulated under the Federal Food Drug and Cosmetic Act and do not
require an MSDS for hazard communication as stated in 29 CFR 1910.1200.

This MSDS is supplied as an additional service.

Comment:



European Union: This product is a medical device and is regulated under the Council Directive
93/42/EEC (commonly known as the Medical Device Directive). Medical devices do not require a safety
data sheet for hazard communication.

This safety data sheet is supplied as an additional service.
Safety Phrase
Hazardous chemicals according to Risk Phrase
Directive 67/548/EEC and later amendments
None None None


Comment:



SECTION 16. - - - - - - - - - - - OTHER INFORMATION - - - - - - - - - -




THE ABOVE INFORMATION HAS BEEN COMPILED FROM SOURCES BELIEVED TO BE RELIABLE AND IS
ACCURATE TO THE BEST OF OUR KNOWLEDGE. HOWEVER, COLOPLAST CORP. CANNOT GIVE ANY
GUARANTEES REGARDING INFORMATION FROM OTHER SOURCES AND EXPRESSLY DOES NOT MAKE ANY
WARRANTIES, NOR ASSUMES ANY LIABILITY, FOR ITS USE.
Material Safety Data Sheet (MSDS)
Assura庐 AC 3 _鈥? (90mm) 鈥? Closed Pouch

MATERIAL SAFETY DATA SHEET:
Reference: This MSDS is prepared to comply with: 29 CFR 1910.1200; Directive 91/155/EEC.

SECTION 1. - - - - - - - - - - IDENTIFICATION OF PRODUCT AND COMPANY - - - - - - - - - -


PRODUCT NAME Assura庐 Adhesive Coupling Two Piece Closed Pouch 鈥? 90 mm classic
PRODUCT CODE 14317
Product Information: Ostomy

Manufacturer: Coloplast A/S
Holtedam 1
DK-3050 Humleb忙k
Denmark
Telephone: +45 49 11 11 11 Fax: +45 49 11 22 60


SECTION 2. - - - - - - - - - COMPOSITION / INFORMATION ON INGREDIENTS - - - - - - - - - - -

This product does not contain substances classified as hazardous under EC nor US OSHA regulations.
Main ingredients and packaging materials are listed below.

EC-No.
Chemical Name CAS -No.

Ostomy Pouch
CPE (Chlorinated polyethylene) 64754-90-1
EVA (Ethylenevinylacetate) 24937-78-8
PVdC (Polyvinyl dichloride) 9002-85-1
Plasticizer (poxydized soyabeanoil) 8013-07-8
Polyester 25038-59-9
PE (Polyethylene) 9002-88-4
Activated carbon 7440-44-0
PE-foam -
Polyurethane foam -
Adhesive -

Packaging:
PE (polyehtylene) 9002-88-4
Corrugared Cardboard
Paper




SECTION 3. - - - - - - - - - - HAZARDS IDENTIFICATION - - - - - - - - - -


This product consists primarily of polymer materials. Products poses no immediate hazard, but can give
rise to toxic fumes in a fire.
SECTION 4. - - - - - - - - - - FIRST-AID MEASURES - - - - - - - - - -

In Case of Eye Contact: Not relevant
In Case of Skin Contact: This product is intended to be in contact with the skin when used as directed
in the instructions for use
If Inhaled: Not relevant
If Ingested/Swallowed: Not relevant
Other: Show this Safety Data Sheet to a physician or emergency ward.

SECTION 5. - - - - - - - - - - FIRE FIGHTING MEASURES - - - - - - - - - -

Extinguishing Media: Use water spray, carbon dioxide, dry chemical powder or appropriate foam.
Special Firefighting Procedures: Keep personnel removed from and upwind of fire. Wear full fire
fighting turnout gear and respiratory protection.
Exposure Hazard: Smoke, soot, CO/CO2, and other toxic fumes. Avoid contact with heated or molten
product. Do not breathe vapors from heated product.


SECTION 6. - - - - - - - - - - ACCIDENTAL RELEASE MEASURES - - - - - - - - - -

No specific measures

SECTION 7. - - - - - - - - - - HANDLING AND STORAGE - - - - - - - - - -

Handling: See instructions for use.
Storage: Store until use as supplied and at normal temperatures


SECTION 8. - - - - - - - - - - EXPOSURE CONTROLS / PERSONAL PROTECTION - - - - - - - - - -

Engineering Measures: None required
Personal Protective Measures: None required
Exposure limit values: None


SECTION 9. - - - - - - - - - - PHYSICAL AND CHEMICAL PROPERTIES - - - - - - - - - -

Appearance:
Odor: None
Physical State: Solid
pH: Not applicable
Vapor Pressure: Not applicable
Vapor Density: Not applicable
Boiling Point: Not applicable
Melting Point/Freezing Point: Not applicable
Solubility: Not applicable
Density: Not applicable
Flash Point: Unknown


SECTION 10. - - - - - - - - - - STABILITY AND REACTIVITY - - - - - - - - - -

Stability: The product is stable under ambient conditions
Conditions to avoid: High temperatures
Materials to avoid: None known
Hazardous Decomposition Products: Heating may produce toxic fumes
Hazardous polymerization: No


SECTION 11. - - - - - - - - - - TOXICOLOGICAL INFORMATION - - - - - - - - - -

This product is a medical device and has been evaluated according to the requirements of medical
devices. According to current knowledge this product is considered non-toxic.

For further information please contact Coloplast A/S at the telephone number found in section 1.

SECTION 12. - - - - - - - - - - ECOLOGICAL INFORMATION - - - - - - - - - -

Ecotoxicological data have not been determined specifically for this product. Based on toxicity data on
the ingredients no ecotoxicological effects are expected. However, the product is not biodegradable and
discharge to the environment should be avoided.

For further information please contact Coloplast A/S at the telephone number found in section 1.

SECTION 13. - - - - - - - - - - DISPOSAL CONSIDERATIONS - - - - - - - - - -

The recommended disposal technology is incineration at any approved facility. The disposal should
always be in compliance with National, Federal, State and local regulations. The product should not be
discharged to the environment.

US: If this product as supplied becomes a waste, is does not meet the criteria of a hazardous waste as
defined under the Ressource Conservation and Recovery Act (RCRA) 40 CFR 261.

European Union: Per The European Waste Catalogue (EWC), in accordance with EC Directive
75/442/EEC, the following Waste Code can be used: 18 01 04 00 wastes whose collection and disposal is
not subject to special requirements in view of the prevention of infection (e.g. dressings, plaster casts,
linen, disposable clothing, diapers). However, if the waste in view of the prevention of infection needs
special requirements, other Waste Codes should be used. It is the responsibility of the holder of the waste
to determine the actual classification. Waste from private household may be disposed of together with
other household waste.

SECTION 14. - - - - - - - - - - TRANSPORT INFORMATION - - - - - - - - - -

Not dangerous goods (ADR 2003, RID, DOT).

SECTION 15. - - - - - - - - - - - REGULATORY INFORMATION - - - - - - - - - -

United States: This product is regulated under the Federal Food Drug and Cosmetic Act and do not
require an MSDS for hazard communication as stated in 29 CFR 1910.1200.

This MSDS is supplied as an additional service.

Comment:



European Union: This product is a medical device and is regulated under the Council Directive
93/42/EEC (commonly known as the Medical Device Directive). Medical devices do not require a safety
data sheet for hazard communication.
This safety data sheet is supplied as an additional service.

Safety Phrase
Hazardous chemicals according to Risk Phrase
Directive 67/548/EEC and later amendments
None None None


Comment:



SECTION 16. - - - - - - - - - - - OTHER INFORMATION - - - - - - - - - -




THE ABOVE INFORMATION HAS BEEN COMPILED FROM SOURCES BELIEVED TO BE RELIABLE AND IS
ACCURATE TO THE BEST OF OUR KNOWLEDGE. HOWEVER, COLOPLAST CORP. CANNOT GIVE ANY
GUARANTEES REGARDING INFORMATION FROM OTHER SOURCES AND EXPRESSLY DOES NOT MAKE ANY
WARRANTIES, NOR ASSUMES ANY LIABILITY, FOR ITS USE.
Material Safety Data Sheet (MSDS)
Assura庐 AC 3 _鈥? (90mm) 鈥? EasiClose Pouch

MATERIAL SAFETY DATA SHEET:
Reference: This MSDS is prepared to comply with: 29 CFR 1910.1200; Directive 91/155/EEC.

SECTION 1. - - - - - - - - - - IDENTIFICATION OF PRODUCT AND COMPANY - - - - - - - - - -


PRODUCT NAME Assura庐 Adhesive Coupling Two Piece Open Pouch - 90 mm. classic
PRODUCT CODE 14379
Product Information: Ostomy

Manufacturer: Coloplast A/S
Holtedam 1
DK-3050 Humleb忙k
Denmark
Telephone: +45 49 11 11 11 Fax: +45 49 11 22 60


SECTION 2. - - - - - - - - - COMPOSITION / INFORMATION ON INGREDIENTS - - - - - - - - - - -

This product does not contain substances classified as hazardous under EC nor US OSHA regulations.
Main ingredients and packaging materials are listed below.

EC-No.
Chemical Name CAS -No.

Ostomy Pouch:
CPE ( Chlorinated Polyethylene) 64754-90-1
EVA (Ethylenevinylacetate) 24937-78-8
PVdC (Polyvinyl dichloride) 9002-85-1
Plasticizer (epoxydized soybeanoil) 8013-07-8
Polyester 25038-59-9
PE (polyethylene) 9002-88-4
Activated carbon 7440-44-0
PE-foam -
Polyurethane foam -
PA (Polyamide) -
PP (Polypropylene) -
Adhesive -

Packaging:
PE (polyethylene)
Corrugated Cardboard




SECTION 3. - - - - - - - - - - HAZARDS IDENTIFICATION - - - - - - - - - -
PaperThis product consists primarily of polymer materials. Products poses no immediate hazard, but can
give rise to toxic fumes in a fire.

SECTION 4. - - - - - - - - - - FIRST-AID MEASURES - - - - - - - - - -

In Case of Eye Contact: Not relevant
In Case of Skin Contact: This product is intended to be in contact with the skin when used as directed
in the instructions for use
If Inhaled: Not relevant
If Ingested/Swallowed: Not relevant
Other: Show this Safety Data Sheet to a physician or emergency ward.

SECTION 5. - - - - - - - - - - FIRE FIGHTING MEASURES - - - - - - - - - -

Extinguishing Media: Use water spray, carbon dioxide, dry chemical powder or appropriate foam.
Special Firefighting Procedures: Keep personnel removed from and upwind of fire. Wear full fire
fighting turnout gear and respiratory protection.
Exposure Hazard: Smoke, soot, CO/CO2, and other toxic fumes. Avoid contact with heated or molten
product. Do not breathe vapors from heated product.


SECTION 6. - - - - - - - - - - ACCIDENTAL RELEASE MEASURES - - - - - - - - - -

No specific measures

SECTION 7. - - - - - - - - - - HANDLING AND STORAGE - - - - - - - - - -

Handling: See instructions for use.
Storage: Store until use as supplied and at normal temperatures


SECTION 8. - - - - - - - - - - EXPOSURE CONTROLS / PERSONAL PROTECTION - - - - - - - - - -

Engineering Measures: None required
Personal Protective Measures: None required
Exposure limit values: None


SECTION 9. - - - - - - - - - - PHYSICAL AND CHEMICAL PROPERTIES - - - - - - - - - -

Appearance:
Odor: None
Physical State: Solid
pH: Not applicable
Vapor Pressure: Not applicable
Vapor Density: Not applicable
Boiling Point: Not applicable
Melting Point/Freezing Point: Not applicable
Solubility: Not applicable
Density: Not applicable
Flash Point: Unknown


SECTION 10. - - - - - - - - - - STABILITY AND REACTIVITY - - - - - - - - - -
Stability: The product is stable under ambient conditions
Conditions to avoid: High temperatures
Materials to avoid: None known
Hazardous Decomposition Products: Heating may produce toxic fumes
Hazardous polymerization: No


SECTION 11. - - - - - - - - - - TOXICOLOGICAL INFORMATION - - - - - - - - - -

This product is a medical device and has been evaluated according to the requirements of medical
devices. According to current knowledge this product is considered non-toxic.

For further information please contact Coloplast A/S at the telephone number found in section 1.

SECTION 12. - - - - - - - - - - ECOLOGICAL INFORMATION - - - - - - - - - -

Ecotoxicological data have not been determined specifically for this product. Based on toxicity data on
the ingredients no ecotoxicological effects are expected. However, the product is not biodegradable and
discharge to the environment should be avoided.

For further information please contact Coloplast A/S at the telephone number found in section 1.

SECTION 13. - - - - - - - - - - DISPOSAL CONSIDERATIONS - - - - - - - - - -

The recommended disposal technology is incineration at any approved facility. The disposal should
always be in compliance with National, Federal, State and local regulations. The product should not be
discharged to the environment.

US: If this product as supplied becomes a waste, is does not meet the criteria of a hazardous waste as
defined under the Ressource Conservation and Recovery Act (RCRA) 40 CFR 261.

European Union: Per The European Waste Catalogue (EWC), in accordance with EC Directive
75/442/EEC, the following Waste Code can be used: 18 01 04 00 wastes whose collection and disposal is
not subject to special requirements in view of the prevention of infection (e.g. dressings, plaster casts,
linen, disposable clothing, diapers). However, if the waste in view of the prevention of infection needs
special requirements, other Waste Codes should be used. It is the responsibility of the holder of the waste
to determine the actual classification. Waste from private household may be disposed of together with
other household waste.

SECTION 14. - - - - - - - - - - TRANSPORT INFORMATION - - - - - - - - - -

Not dangerous goods (ADR 2003, RID, DOT).

SECTION 15. - - - - - - - - - - - REGULATORY INFORMATION - - - - - - - - - -

United States: This product is regulated under the Federal Food Drug and Cosmetic Act and do not
require an MSDS for hazard communication as stated in 29 CFR 1910.1200.

This MSDS is supplied as an additional service.

Comment:
European Union: This product is a medical device and is regulated under the Council Directive
93/42/EEC (commonly known as the Medical Device Directive). Medical devices do not require a safety
data sheet for hazard communication.

This safety data sheet is supplied as an additional service.

Safety Phrase
Hazardous chemicals according to Risk Phrase
Directive 67/548/EEC and later amendments
None None None


Comment:



SECTION 16. - - - - - - - - - - - OTHER INFORMATION - - - - - - - - - -




THE ABOVE INFORMATION HAS BEEN COMPILED FROM SOURCES BELIEVED TO BE RELIABLE AND IS
ACCURATE TO THE BEST OF OUR KNOWLEDGE. HOWEVER, COLOPLAST CORP. CANNOT GIVE ANY
GUARANTEES REGARDING INFORMATION FROM OTHER SOURCES AND EXPRESSLY DOES NOT MAKE ANY
WARRANTIES, NOR ASSUMES ANY LIABILITY, FOR ITS USE.

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