Model: 168350
Catalog: 16835
DI: 05701780444620
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:
50b175c8-d4ba-4e3d-82a2-c3c147266e0c
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:
05701780444637
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
05701780444620
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
05701780444620
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
05701780444644
Item #3 - Device ID Type:
Unit of Use
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 64583
Name: One-piece urostomy bag, open-ended
Definition:
A one-piece plastic pouch designed to be attached with adhesive to a patient's skin around a stoma for use as a urine collection device in the management of urinary diversions; it includes a drainage tap to permit the emptying of fluids (open-ended). The entire device is removed when 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 Text:
Base Plate Max Cut Size - mm 23
Item #2 - Size Type:
Device Size Text, specify
Item #3 - Size Text:
Base Plate Precut Start Hole Size - in 3/8
Item #3 - Size Type:
Device Size Text, specify
Item #4 - Size Text:
Base Plate Type Convex Light
Item #4 - Size Type:
Device Size Text, specify
Item #5 - Size Text:
Base Plate Max Cut Size - in 7/8
Item #5 - Size Type:
Device Size Text, specify
Item #6 - Size Text:
Base Plate Precut Start Hole Size - mm 10
Item #6 - Size Type:
Device Size Text, specify
Environmental Conditions
Storage Handling - Storage Handling Type:
Special Storage Condition, Specify
Storage Handling - Storage Handling Special Condition Text:
This way up.