FDA.reportPublic FDA data

BioPlus+

Primary DI
00653599000670
Brand
BioPlus+
Company
ARGENTUM MEDICAL, LLC
Model
52301
Catalog number
31150
Device description
BioPlus+ Wipe
Published
2020-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10653599000677PackageGS110In Commercial Distribution
00653599000670PrimaryGS10
M456523010SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1065359900067710653599000677
00653599000670006535990006706535990006700653599000670

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic-polymer liquid barrier dressingA liquid preparation composed of synthetic polymer materials intended to form a thin protective film when applied to superficial wounds (e.g., minor cuts, abrasions) and/or intact skin (typically sensitive areas such as around a stoma), to reduce exposure to external contaminants; may also be intended to augment the adherence of medical adhesives, or provide a protective interface when removing medical adhesives. It may be presented as a wipe, swab, or spray. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
800-864-6755CustomerCare@BioDermInc.com

Regulatory Flags#

DUNS number
091449079
Device count
1
Premarket exempt
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
00653599000250CathGrip511002020-01-07
00653599000274CathGrip51250BOM51250BX2020-01-07
00653599000298CathGrip51250NSBOM51250NSBX2020-01-08
00653599000311CathGrip51250NSNA2020-01-08
00653599000328CathGrip51250NSNW2020-01-16
00653599000342CathGrip51250SFPNA2021-05-12
00653599000366CathGrip51300BOM51300BX2020-01-07
00653599000373CathGrip51300NSBOM51300NSBX2020-01-08
00653599000380CathGrip51300NSNA2020-01-09
00653599000397CathGrip51300SFP2020-01-16
00653599000403CathGrip51300SFPNA2020-01-16
00653599000410CathGrip51301BOM51301BX2020-01-07
00653599000434CathGrip51301NSBOM51301NSBX2020-01-08
00653599000458CathGrip51301NSNA2020-01-16
00653599000489CathGrip51301SFP2020-01-16
00653599000496CathGrip51301SFPNA2020-07-07
00653599000519CathGrip513032020-01-07
00653599000526CathGrip51350BOM51350BX2020-01-07
00653599000533CathGrip51350NSBOM51350NSBX2020-01-08
00653599000540CathGrip51350NSNA2023-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00311917088556WalgreensWALGREEN CO.KGX2026-09-30
08859922800036EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800043EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800050EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800067EquateWAL-MART STORES, INC.KGX2026-09-30
00850087488877CeeportCEEPORT INC.KGX2026-09-29
00197998095641Transpore™Solventum US LLCKGX2026-09-25
00197998095672Transpore™Solventum US LLCKGX2026-09-25
00197998095702Transpore™Solventum US LLCKGX2026-09-25
00197998095733Transpore™Solventum US LLCKGX2026-09-25
00197998095788Transpore™Solventum US LLCKGX2026-09-25
00197998103612Transpore™Solventum US LLCKGX2026-09-25
00197998103636Transpore™Solventum US LLCKGX2026-09-25
00197998164118Transpore™Solventum US LLCKGX2026-09-25
06979191883744OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883751OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883768OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883775OKTAPEHTT Technologies, Inc.KGX2026-09-02
00850087488785CeeportCEEPORT INC.KGX2026-08-26
00850087488792CeeportCEEPORT INC.KGX2026-08-26
00197998149016Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149047Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149078Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149382Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149412Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149443Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149474Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149504Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998185557Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00029369133334McDavidShock Doctor, Inc.KGX2026-08-18