FDA.reportPublic FDA data

H-Chlor® Solution

Primary DI
00339328064129
Brand
H-Chlor® Solution
Company
PATRIN PHARMA, INC.
Model
H-Chlor® 12
Catalog number
39328-064-12
Device description
H-Chlor® 12 solution is a clear liquid for cleaning open wounds.
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FQHLavage, Jet

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00339328064129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00339328064129003393280641293393280641290339328064129

GMDN Terms#

Term, Definition table
TermDefinition
Antimicrobial wound irrigation solution, non-sterileA non-sterile 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 debridment and to moisten a wound dressing(s), and to support natural healing. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806841677
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00339328067120H-Chlor® SolutionH-Chlor® 12 Wound Therapy Solution39328-067-122019-08-07
00339328068080H-Chlor® SolutionH-Chlor® 12 Wound Spray39328-068-082019-08-07
00339328065065H-Chlor® SolutionH-Chlor® 639328-065-062016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051471221512De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2026-05-27
B674PL30010PerilavStiehl Tech, LLCFQH2026-05-13
B674T93LF10PerilavStiehl Tech, LLCFQH2026-05-13
07640407460811debritom+Medaxis AGFQH2026-04-17
07649996166302debritom+Medaxis AGFQH2026-04-17
07649996166043debritom+Medaxis AGFQH2026-04-08
04050147023826ErbeErbe Elektromedizin GmbHFQH2026-04-01
00382909101201SurgiphorCAREFUSION 2200, INCFQH2026-03-05
00075450844337Hy-Vee Saline Wound WashHY-VEE, INC.FQH2026-02-19
00850073677032Shur-ClensAsept Pak, Inc.FQH2026-02-17
00850073677056Skin-ClensAsept Pak, Inc.FQH2026-02-17
04050147022959ErbeErbe Elektromedizin GmbHFQH2025-10-01
04050147022942ErbeErbe Elektromedizin GmbHFQH2025-09-30
10850073677008Shur-ClensAsept Pak, Inc.FQH2025-04-30
10860006476035Shur-ClensAsept Pak, Inc.FQH2025-04-23
10850073677015Shur-ClensAsept Pak, Inc.FQH2025-04-16
10860006476028Shur-ClensAsept Pak, Inc.FQH2025-04-16
10842351180027Irrisept Accessory KitIRRIMAX CORPORATIONFQH2024-07-22
10842351120047Irrisept Antimicrobial Wound LavageIRRIMAX CORPORATIONFQH2024-07-16
10842351180010Irrisept Wound Solution KitIRRIMAX CORPORATIONFQH2024-07-01
03600040955086ElefantColoplast A/SFQH2024-04-05
03600040955116ElefantColoplast A/SFQH2024-04-05
03600040970614ElefantColoplast A/SFQH2024-04-05
03600040970645ElefantColoplast A/SFQH2024-04-05
03600040970676ElefantColoplast A/SFQH2024-04-05
03600040970737ElefantColoplast A/SFQH2024-04-05
03600040970768ElefantColoplast A/SFQH2024-04-05
03600040970799ElefantColoplast A/SFQH2024-04-05
00034197018470Premier Solution Saline Wound WashPremier Brands of America Inc.FQH2024-03-12
00032251985164Family Wellness Saline Wound WashFamily Dollar StoresFQH2024-03-10