Model: 122920
Catalog: 122920
DI: 05701780434508
Status: New
MRI: MR Safe
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-04-30
Current Version: 2026-05-08
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b2242dbd-a7dc-4138-8d22-6a9957efd56f
Distribution Status:
In Commercial Distribution
DUNS Number:
305524696
Device Count:
10
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
Shipper Box
Item #1 - Device ID:
05701780434515
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
05701780434508
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
05701780434508
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
05701780434522
Item #3 - Device ID Type:
Unit of Use
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 31069
Name: Multiple-piece urostomy bag, open-ended
Definition:
A plastic pouch composed of two or more parts [e.g., a barrier (wafer) and a pouch; both having flange/locking mechanisms] designed to attach to a patient's skin around a stoma for use as a urinary collection device in the management of urinary diversions. It has a non-return valve to prevent urine from pooling at the base of the stoma. It also has a drainage tap to permit the emptying of fluids. The barrier (wafer) remains attached around the stoma when the bag is removed/changed. This is a single-use device.
FDA Product Codes
EXB
Collector, ostomy
Device Sizes
Item #1 - Size Text:
Descriptive Bag Size Maxi
Item #1 - Size Type:
Device Size Text, specify
Item #2 - Size - @attributes - Unit:
Millimeter
Item #2 - Size - @attributes - Value:
35
Item #2 - Size Type:
Lumen/Inner Diameter
Item #3 - Size Text:
Coupling Size Diameter - in 1 3/8
Item #3 - Size Type:
Device Size Text, specify