Model: 122970
Catalog: 122970
DI: 05701780435239
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:
79c601f0-bb52-4e7d-82e7-d11685c590fc
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:
05701780435246
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
05701780435239
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
05701780435239
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
05701780435253
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 - @attributes - Unit:
Millimeter
Item #1 - Size - @attributes - Value:
50
Item #1 - Size Type:
Lumen/Inner Diameter
Item #2 - Size Text:
Descriptive Bag Size Maxi
Item #2 - Size Type:
Device Size Text, specify
Item #3 - Size Text:
Coupling Size Diameter - in 2
Item #3 - Size Type:
Device Size Text, specify