Karaya 5 7910

GUDID 20610075079104

Ostomy Paste

HOLLISTER INCORPORATED

Peristomal/periwound dressing

• Primary Device ID: 20610075079104
• NIH Device Record Key: b8038f3a-3eb4-40bb-baaf-eb00eb01600a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Karaya 5
• Version Model Number: 7910
• Catalog Number: 7910
• Company DUNS: 005527098
• Company Name: HOLLISTER INCORPORATED
• Device Count: 12
• 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: false
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com
• Phone: +1(800)323-4060
• Email: cs@hollister.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00610075079100 [Primary]
GS1	00610075172795 [Unit of Use]
GS1	20610075079104 [Package]; Contains: 00610075079100; Package: CAS [7 Units]; In Commercial Distribution

FDA Product Code

• EZR: CEMENT, STOMAL APPLIANCE, OSTOMY

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-09
• Device Publish Date: 2022-12-01

On-Brand Devices [Karaya 5]

• 20610075079104: Ostomy Paste
• 30610075079057: Stoma Powder
• 20610075071696: 1-Piece Closed Ostomy Pouch, Convex
• 20610075071689: 1-Piece Closed Ostomy Pouch, Convex
• 20610075071641: 1-Piece Closed Ostomy Pouch, Convex
• 20610075071634: 1-Piece Closed Ostomy Pouch, Convex
• 20610075036695: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075036688: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075036657: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075036633: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075036626: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075036091: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075036084: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075036053: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075036046: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075036039: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075033298: 1-Piece Closed Ostomy Pouch, Convex
• 20610075033281: 1-Piece Closed Ostomy Pouch, Convex
• 20610075033267: 1-Piece Closed Ostomy Pouch, Convex
• 20610075033250: 1-Piece Closed Ostomy Pouch, Convex
• 20610075033243: 1-Piece Closed Ostomy Pouch, Convex
• 20610075033236: 1-Piece Closed Ostomy Pouch, Convex
• 20610075032796: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075032789: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075032765: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075032758: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075032741: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075032734: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075032390: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075032383: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075032345: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075032338: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075032321: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075032291: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075032284: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075032260: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075032253: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075032246: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075032239: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075032222: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075014396: 1-Piece Urostomy Pouch, Convex
• 20610075014389: 1-Piece Urostomy Pouch, Convex
• 20610075014341: 1-Piece Urostomy Pouch, Convex
• 20610075014334: 1-Piece Urostomy Pouch, Convex
• 20610075014327: 1-Piece Urostomy Pouch, Convex