FDA.reportPublic FDA data

Pure&Clean

Primary DI
00852421007102
Brand
Pure&Clean
Company
Pure & Clean, LLC
Model
2021.04
Catalog number
2SD16
Device description
Pure&Clean Sports Skin Defense
Published
2023-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852421007102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852421007102008524210071028524210071020852421007102

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 Volume16Fluid Ounce

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius0 Degrees Celsius
Storage Environment Temperature32 Degrees Fahrenheit0 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
417-243-0000info@pncvision.com

Regulatory Flags#

DUNS number
045315650
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852421007874Pure&Clean2025.121WC4-RXP2026-02-27
00852421007867Pure&Clean2025.112025-12-12
00852421007225Pure&Clean 19.081HG32023-08-04
00739189359158Pure&Clean None1WC82023-08-08
00852421007331Pure&Clean 22.063HP22023-08-11
00852421007348Pure&Clean 23.033HP82023-08-11
00852421007461Pure&Clean 22.084HP82023-08-11
00852421007577Pure&Clean None4HP22023-08-11
00852421007669Pure&Clean 2020.031HC22023-08-11
00852421007676Pure&Clean 2020.041HC82023-08-11
00852421007720Pure&Clean 2020.084HPG2023-08-11
00852421007737Pure&Clean 2020.081HCG2023-08-11
00852421007386Pure&Clean 2-25-2011WC16-ZRXP2023-08-08
00852421007393Pure&Clean None11WC16-ZRXI2023-08-08
00852421007409Pure&Clean194WC4RX-211WC4-ZRX2023-08-08
00852421007492Pure&Clean None11VC2-Z2023-08-08
00852421007508Pure&Clean 2-25-2011WC2-Z2023-08-08
00852421007515Pure&Clean 2-25-2011WC8-Z2023-08-08
00852421007522Pure&Clean 194HG3-211HG3-Z2023-08-08
00852421007539Pure&Clean None11HG8-Z2023-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344175994MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-20
09551012610035ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610196ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610363ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610370ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
10192253046403KendallCardinal Health 200, LLCFRO2026-03-25
10192253046519KendallCardinal Health 200, LLCFRO2026-03-25
09120073781536GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781543GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781550GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781567GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781574GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
10197344169412MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05
10197344169443MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05
10197344169467MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169474MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169481MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169498MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169504MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344170197MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-10-13
10192253046274KendallCardinal Health 200, LLCFRO2025-09-22
10192253047837XeroformCardinal Health 200, LLCFRO2025-09-22
10192253047844XeroformCardinal Health 200, LLCFRO2025-09-22
10192253047851XeroformCardinal Health 200, LLCFRO2025-09-22
10192253047868XeroformCardinal Health 200, LLCFRO2025-09-22
10192253047806XeroformCardinal Health 200, LLCFRO2025-09-10
10192253046311KendallCardinal Health 200, LLCFRO2025-09-09
10192253046373KendallCardinal Health 200, LLCFRO2025-09-09
10192253046472KendallCardinal Health 200, LLCFRO2025-09-09
10192253046540KendallCardinal Health 200, LLCFRO2025-09-09