Model: Version
DI: 00199874551753
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-04-27
Current Version: 2026-05-05
Description
Lulifi 8oz Skin Barrier
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
ab67b87d-667a-4529-b7d9-4ef08d51bc53
Distribution Status:
In Commercial Distribution
DUNS Number:
144478985
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
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
Device ID:
00199874551753
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 59523
Name: Antimicrobial wound irrigation solution
Definition:
A solution that includes an antimicrobial agent (e.g., sodium hypochlorite) intended to be used to irrigate and clean acute or chronic wounds, including first or second degree burns, to aid in autolytic debridement and to moisten a wound dressing(s), and to support natural healing. It is intended to be used in the home or healthcare facility. After application, this device cannot be reused.
FDA Product Codes
FRO
Dressing, Wound, Drug