Device
ProComfortMax Extra Protective Bariatric Briefs Size C Up to 110"
Manufacturer
Twin Med, LLC
Model: PCEPBB-C Catalog: PCEPBB-C DI: 10840330704837 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: No OTC: Yes
First Published: 2026-04-28 Current Version: 2026-05-06
Description
ProComfortMax Extra Protective Bariatric Briefs Size C Up to 110"
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 32e893ea-a911-4491-9994-f9ea2a61ac06
Distribution Status: In Commercial Distribution
DUNS Number: 107071289
Device Count: 8
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: Yes
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: Yes
Identifiers
Item #1 - Pkg Type: Case
Item #1 - Device ID: 30840330704831
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 4
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 10840330704837
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 10840330704837
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
Item #3 - Device ID: 00840330704830
Item #3 - Device ID Type: Unit of Use
Item #3 - Device ID Issuing Agency: GS1
GMDN
Code: 11239
Name: Adult nappy
Definition:
A disposable undergarment (a nappy or diaper) composed of absorbent material and worn between the legs used to collect urine and faeces from an incontinent adult patient. This is a single-use device.
FDA Product Codes
EYQ
Garment, Protective, For Incontinence