Device
ProComfortMax Extra Protective Bariatric Briefs Size B Up to 100"
Manufacturer
Twin Med, LLC
Twin Med, LLC
Model: PCEPBB-B
Catalog: PCEPBB-B
DI: 10840330704820
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 B Up to 100"
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
109e7690-717a-4939-ab98-573f51edbb1e
Distribution Status:
In Commercial Distribution
DUNS Number:
107071289
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:
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:
30840330704824
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
4
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10840330704820
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10840330704820
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
00840330704823
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