Pouchkins 3761

GUDID 20610075110524

2-Piece Pediatric Ostomy Skin Barrier, SoftFlex

HOLLISTER INCORPORATED

Intestinal ostomy base plate, flat Intestinal ostomy base plate, flat Intestinal ostomy base plate, flat Intestinal ostomy base plate, flat Intestinal ostomy base plate, flat Intestinal ostomy base plate, flat Intestinal ostomy base plate, flat Intestinal ostomy base plate, flat Intestinal ostomy base plate, flat Intestinal ostomy base plate, flat Intestinal ostomy base plate, flat Intestinal ostomy base plate, flat

• Primary Device ID: 20610075110524
• NIH Device Record Key: 13929a0f-3d41-4d5d-a19f-7a626e9b4dd7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pouchkins
• Version Model Number: 3761
• Catalog Number: 3761
• Company DUNS: 005527098
• Company Name: HOLLISTER INCORPORATED
• Device Count: 5
• 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: 44 Millimeter
• Lumen/Inner Diameter: 32 Millimeter
• Lumen/Inner Diameter: 44 Millimeter
• Lumen/Inner Diameter: 32 Millimeter
• Lumen/Inner Diameter: 44 Millimeter
• Lumen/Inner Diameter: 32 Millimeter
• Lumen/Inner Diameter: 44 Millimeter
• Lumen/Inner Diameter: 32 Millimeter
• Lumen/Inner Diameter: 44 Millimeter
• Lumen/Inner Diameter: 32 Millimeter
• Lumen/Inner Diameter: 44 Millimeter
• Lumen/Inner Diameter: 32 Millimeter
• Lumen/Inner Diameter: 44 Millimeter
• Lumen/Inner Diameter: 32 Millimeter
• Lumen/Inner Diameter: 44 Millimeter
• Lumen/Inner Diameter: 32 Millimeter
• Lumen/Inner Diameter: 44 Millimeter
• Lumen/Inner Diameter: 32 Millimeter
• Lumen/Inner Diameter: 44 Millimeter
• Lumen/Inner Diameter: 32 Millimeter
• Lumen/Inner Diameter: 44 Millimeter
• Lumen/Inner Diameter: 32 Millimeter
• Lumen/Inner Diameter: 44 Millimeter
• Lumen/Inner Diameter: 32 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00610075083312 [Unit of Use]
GS1	00610075110520 [Primary]
GS1	20610075110524 [Package]; Contains: 00610075110520; Package: CAS [36 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 [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