Device
UltraMax Ileo Pouches Shallow Convex Transparent Cut-to-Fit (Box of 5)
Manufacturer
Marlen Manufacturing And Development Co.
Marlen Manufacturing And Development Co.
Model: 52500
DI: 10661613525006
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
UltraMax Ileo Pouches Shallow Convex Transparent Cut-to-Fit (Box of 5)
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
99922d0e-58b1-4485-8d8b-f4c3f51323bf
Distribution Status:
In Commercial Distribution
DUNS Number:
004220711
Device Count:
5
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 - Device ID:
10661613525006
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00661613525009
Item #2 - Device ID Type:
Unit of Use
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 31075
Name: One-piece intestinal ostomy bag, open-ended
Definition:
A plastic pouch designed to be attached around a stoma for use as a receptacle for intestinal output following a colostomy or ileostomy (effluent is typically of a fluid consistency). It is a one-piece device, typically having a self-adhesive flange, that is removed and disposed of in accordance with the clinician's instructions. The distal end of the pouch can be opened for drainage of the waste (average of 400-800 ml per day) and emptied several times per day. This is a single-use device.
FDA Product Codes
EZS
Appliance, Colostomy, Disposable