Biatain Fiber 33504

GUDID 05708932769365

Coloplast A/S

Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

• Primary Device ID: 05708932769365
• NIH Device Record Key: e314deef-2ad1-429e-927d-ea867365856f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biatain Fiber
• Version Model Number: 33504
• Catalog Number: 33504
• Company DUNS: 305524696
• Company Name: Coloplast A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com
• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com

Device Dimensions

• Device Size Text, specify: 0
• Length: 5 Inch
• Width: 4 Inch
• Length: 12 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Length: 5 Inch
• Width: 4 Inch
• Length: 12 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Length: 5 Inch
• Width: 4 Inch
• Length: 12 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Length: 5 Inch
• Width: 4 Inch
• Length: 12 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Length: 5 Inch
• Width: 4 Inch
• Length: 12 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Length: 5 Inch
• Width: 4 Inch
• Length: 12 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Length: 5 Inch
• Width: 4 Inch
• Length: 12 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Length: 5 Inch
• Width: 4 Inch
• Length: 12 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Length: 5 Inch
• Width: 4 Inch
• Length: 12 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Length: 5 Inch
• Width: 4 Inch
• Length: 12 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Length: 5 Inch
• Width: 4 Inch
• Length: 12 Centimeter
• Width: 10 Centimeter
• Device Size Text, specify: 0
• Length: 5 Inch
• Width: 4 Inch
• Length: 12 Centimeter
• Width: 10 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708932769341 [Primary]
GS1	05708932769358 [Package]; Contains: 05708932769341; Package: Retail Box [10 Units]; In Commercial Distribution
GS1	05708932769365 [Package]; Contains: 05708932769358; Package: Shipper Box [40 Units]; In Commercial Distribution

FDA Product Code

• NAC: Dressing, wound, hydrophilic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-20
• Device Publish Date: 2024-12-12

On-Brand Devices [Biatain Fiber]

• 05708932769426: 33508
• 05708932769396: 33506
• 05708932769365: 33504
• 05708932769334: 33501