Pouchkins

GUDID 20610075037784

Newborn One-Piece Ostomy Pouch – Flat Cut-to-Fit Barrier_35x22mm 1-3/8x7/8"

HOLLISTER INCORPORATED

One-piece intestinal ostomy bag, open-ended

• Primary Device ID: 20610075037784
• NIH Device Record Key: ec6eabf9-7b8a-4c34-ad0f-a2f6686874b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pouchkins
• Version Model Number: 3778
• Company DUNS: 005527098
• Company Name: HOLLISTER INCORPORATED
• Device Count: 15
• 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: false

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
• 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

• Length: 6.5 Inch
• Length: 6.5 Inch
• Length: 6.5 Inch
• Lumen/Inner Diameter: 22 Millimeter
• Lumen/Inner Diameter: 35 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Lumen/Inner Diameter: 35 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Lumen/Inner Diameter: 35 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Lumen/Inner Diameter: 35 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Lumen/Inner Diameter: 35 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Lumen/Inner Diameter: 35 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Lumen/Inner Diameter: 35 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Lumen/Inner Diameter: 35 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Lumen/Inner Diameter: 35 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Lumen/Inner Diameter: 35 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Lumen/Inner Diameter: 35 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Lumen/Inner Diameter: 35 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Lumen/Inner Diameter: 35 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Lumen/Inner Diameter: 35 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Lumen/Inner Diameter: 35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00610075037780 [Primary]
GS1	00610075082063 [Unit of Use]
GS1	20610075037784 [Package]; Contains: 00610075037780; Package: Case [24 Units]; In Commercial Distribution
GS1	30610075037781 [Unit of Use]

FDA Product Code

• EXB: COLLECTOR, OSTOMY
• EXG: BAG, URINE COLLECTING, URETEROSTOMY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-12-11
• Device Publish Date: 2018-01-01

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