Karaya 5 3222

GUDID 20610075032222

1-Piece Drainable Ostomy Pouch, Convex

HOLLISTER INCORPORATED

One-piece intestinal ostomy bag, open-ended

• Primary Device ID: 20610075032222
• NIH Device Record Key: 6b6bd937-94af-420f-8f3b-b899900d4a07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Karaya 5
• Version Model Number: 3222
• Catalog Number: 3222
• Company DUNS: 005527098
• Company Name: HOLLISTER INCORPORATED
• Device Count: 30
• 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: 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

Device Dimensions

• Lumen/Inner Diameter: 15 Millimeter
• Lumen/Inner Diameter: 15 Millimeter
• Lumen/Inner Diameter: 15 Millimeter
• Lumen/Inner Diameter: 15 Millimeter
• Lumen/Inner Diameter: 15 Millimeter
• Lumen/Inner Diameter: 15 Millimeter
• Lumen/Inner Diameter: 15 Millimeter
• Lumen/Inner Diameter: 15 Millimeter
• Lumen/Inner Diameter: 15 Millimeter
• Lumen/Inner Diameter: 15 Millimeter
• Lumen/Inner Diameter: 15 Millimeter
• Lumen/Inner Diameter: 15 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00610075032228 [Primary]
GS1	00610075083015 [Unit of Use]
GS1	20610075032222 [Package]; Contains: 00610075032228; Package: CAS [12 Units]; In Commercial Distribution

FDA Product Code

• EXB: COLLECTOR, 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]

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• 20610075033281: 1-Piece Closed Ostomy Pouch, Convex
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• 20610075033243: 1-Piece Closed Ostomy Pouch, Convex
• 20610075033236: 1-Piece Closed Ostomy Pouch, Convex
• 20610075032796: 1-Piece Drainable Ostomy Pouch, Convex
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• 20610075032246: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075032239: 1-Piece Drainable Ostomy Pouch, Convex
• 20610075032222: 1-Piece Drainable Ostomy Pouch, Convex
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