FDA.reportPublic FDA data

Anasept Antimicrobial Skin and Wound Cleanser

Primary DI
00367180400083
Brand
Anasept Antimicrobial Skin and Wound Cleanser
Company
ANACAPA TECHNOLOGIES, INC.
Model
4008C
Catalog number
4008C
Device description
Anasept® Antimicrobial Skin and Wound Cleanser is a clear, isotonic liquid that helps in the mechanical removal of the debris from the application site; while delivering 0.057% broad spectrum antimicrobial sodium hypochlorite. Anasept® also inhibits the growth of bacteria such as Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Serratia marcescens, Acinetobacter baumannii, Clostridium difficile and antibiotic resistant strains such as Methicillin resistant Staphylococcus aureus (MRSA), Vancomycin resistant Enterococcus faecalis (VRE), Carbapenem resistant E.coli (CRE) that are commonly found in wound bed as well as fungi such as Aspergillus niger, Candida albicans and Candida auris.
Published
2020-06-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQHLavage, Jet
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073547000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073547000ANASEPT ANTIMICROBIAL SKIN AND WOUND CLEANSERS; ANASEPT ANTIMICROBIAL SKIN AND WOUND GELAnacapa Technologies, Inc.2008-04-23FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00367180412086PackageGS112In Commercial Distribution
00367180400083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00367180412086003671804120863671804120860367180412086
00367180400083003671804000833671804000830367180400083

GMDN Terms#

Term, Definition table
TermDefinition
Antimicrobial wound irrigation solutionA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume8Fluid Ounce

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze

Contacts#

Phone, Email table
PhoneEmail
9093947795anacapa@anacapa-tech.net

Regulatory Flags#

DUNS number
073189370
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00367180400120Anasept Antimicrobial Skin and Wound Cleanser4012SC4012SC2020-06-08
00367180400168Anasept Antimicrobial Skin and Wound Cleanser4016C4016C2020-07-28
00367180400885Anasept Antimicrobial Skin and Wound Cleanser4008SC4008SC2020-06-08
00367180408881Anasept Antimicrobial Skin and Wound Cleanser4008TC4008TC2020-06-22
00367180416169Anasept Antimicrobial Wound Irrigation Solution4160IC4160IC2020-06-22
00367180412888Anasept Antimicrobial Skin and Wound Cleanser4008SC4008SC2020-06-08
00367180400441Anasept Antimicrobial Skin and Wound Cleanser4004SC4004SC2020-08-28
00367180400045Anasept Antimicrobial Skin and Wound Cleanser4004C4004C2020-07-29
00367180300154Silver-sept Silver Antimicrobial Skin and Wound Gel3015S3015S2020-11-23
00367180312157Silver-sept Silver Antimicrobial Skin and Wound Gel3015S3015S2020-11-23
00367180300031Silver-sept Silver Antimicrobial Skin and Wound Gel3003S3003S2020-10-22
00367180412161Anasept Antimicrobial Skin and Wound Cleanser4016C4016C2020-07-28
00367180500158Anasept Antimicrobial Skin and Wound Gel5015G5015G2020-07-27
00367180512151Anasept Antimicrobial Skin and Wound Gel5015G5015G2020-07-27
00367180500035Anasept Antimicrobial Skin and Wound Gel5003G5003G2020-07-06
00367180412123Anasept Antimicrobial Skin and Wound Cleanser4012SC4012SC2020-06-08
00367180512038Anasept Antimicrobial Skin and Wound Gel5003G5003G2020-07-06
00367180412086Anasept Antimicrobial Skin and Wound Cleanser4008C4008C2020-06-22
00367180412802Anasept Antimicrobial Skin and Wound Cleanser4008TC4008TC2020-06-22
00367180426168Anasept Antimicrobial Wound Irrigation Solution4160IC4160IC2020-06-22

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