Pouchkins 3797

GUDID 20610075110517

1-Piece Pediatric Urostomy Pouch, SoftFlex

HOLLISTER INCORPORATED

One-piece urostomy bag, open-ended One-piece urostomy bag, open-ended One-piece urostomy bag, open-ended One-piece urostomy bag, open-ended One-piece urostomy bag, open-ended One-piece urostomy bag, open-ended One-piece urostomy bag, open-ended One-piece urostomy bag, open-ended One-piece urostomy bag, open-ended One-piece urostomy bag, open-ended One-piece urostomy bag, open-ended One-piece urostomy bag, open-ended

• Primary Device ID: 20610075110517
• NIH Device Record Key: 81e0d239-ce33-4889-b0a3-49e4216c8370
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pouchkins
• Version Model Number: 3797
• Catalog Number: 3797
• Company DUNS: 005527098
• Company Name: HOLLISTER INCORPORATED
• Device Count: 10
• 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: 38 Millimeter
• Lumen/Inner Diameter: 38 Millimeter
• Lumen/Inner Diameter: 38 Millimeter
• Lumen/Inner Diameter: 38 Millimeter
• Lumen/Inner Diameter: 38 Millimeter
• Lumen/Inner Diameter: 38 Millimeter
• Lumen/Inner Diameter: 38 Millimeter
• Lumen/Inner Diameter: 38 Millimeter
• Lumen/Inner Diameter: 38 Millimeter
• Lumen/Inner Diameter: 38 Millimeter
• Lumen/Inner Diameter: 38 Millimeter
• Lumen/Inner Diameter: 38 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00610075083367 [Unit of Use]
GS1	00610075110513 [Primary]
GS1	20610075110517 [Package]; Contains: 00610075110513; Package: CAS [24 Units]; In Commercial Distribution

FDA Product Code

• EXG: BAG, URINE COLLECTING, URETEROSTOMY

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 [Pouchkins]

• 20610075037784: Newborn One-Piece Ostomy Pouch – Flat Cut-to-Fit Barrier_35x22mm 1-3/8x7/8"
• 20610075037777: Premie One-Piece Ostomy Pouch – Flat Cut-to-Fit Barrier_15mm 5/8"
• 20610075110531: 2-Piece Pediatric Drainable Ostomy Pouch
• 20610075110524: 2-Piece Pediatric Ostomy Skin Barrier, SoftFlex
• 20610075110517: 1-Piece Pediatric Urostomy Pouch, SoftFlex
• 20610075110500: 1-Piece Pediatric Drainable Ostomy Pouch, SoftFlex
• 10610075110497: 1-Piece Pediatric Drainable Ostomy Pouch, SoftFlex
• 20610075037746: Pediatric Ostomy Belt