Device
EO-100 is a RX only stabilized HOCl (Hypochlorous Acid) Solution in a 16 ounce bottle.
Manufacturer
FACTOR 14 LLC
Model: EO-100 DI: 00860014139154 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-05-01 Current Version: 2026-05-11 Distribution End: 2032-05-01
Description
EO-100 is a RX only stabilized HOCl (Hypochlorous Acid) Solution in a 16 ounce bottle.
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: ef464d96-bafb-4760-8190-8b959a1e03a3
Distribution Status: In Commercial Distribution
DUNS Number: 119521026
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: 00860014139154
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