Pouchkins 3797

GUDID 20610075110517

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

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

EXG	BAG, URINE COLLECTING, URETEROSTOMY

Steralize Prior To Use	false
Device Is Sterile	false

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