FDA.reportPublic FDA data

Basic Series Hydrophobic Dressing Kit, Large

Primary DI
10851978007242
Brand
Basic Series Hydrophobic Dressing Kit, Large
Company
Pensar Medical, LLC
Model
8463540 0585
Device description
Basic Series Hydrophobic Dressing Kit, Large, Case of 10
Published
2022-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OMPNegative Pressure Wound Therapy Powered Suction Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMPNegative Pressure Wound Therapy Powered Suction PumpGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150960000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150960000WoundPro Negative Pressure Wound Therapy SystemPensar Medical, LLC2016-12-01OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851978007242PrimaryGS10
00851978007245Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085197800724210851978007242
00851978007245008519780072458519780072450851978007245

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system dressing setA collection of devices that composes a sterile dressing pack used with the pump and collection container of a negative pressure wound therapy (NPWT) system to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic) and diabetic/pressure ulcers. It typically includes dressing (e.g., open-cell foam or medicated gauze), an airtight adhesive drape, a drain, an evacuation tube, and sterile saline. This is a single-use device.

Regulatory Flags#

DUNS number
079262228
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851978007801Ultra Seal Preferred Strips (5/pouch)8463550 30282025-12-01
00851978007689MicroDoc NPWT System8463550 50042025-03-19
00851978007696MicroDoc NPWT System8463550 50012025-03-19
00851978007702MicroDoc NPWT System8463550 50022025-03-19
00851978007719MicroDoc NPWT System8463550 50062025-03-19
00851978007726MicroDoc NPWT System8463550 50032025-03-19
00851978007733MicroDoc NPWT System8463550 50072025-03-19
00851978007740MicroDoc NPWT System8463550 50112025-03-19
00851978007757MicroDoc NPWT System8463550 50142025-03-19
00851978007764MicroDoc NPWT System8463550 50122025-03-19
00851978007771MicroDoc NPWT System8463550 50162025-03-19
00851978007788MicroDoc NPWT System8463550 50132025-03-19
00851978007795MicroDoc NPWT System8463550 50172025-03-19
10851978007662WoundPro+ Collection Canister8463540 09412025-03-18
10851978007679WoundPro+ 300cc Advanced Canister w/8' Tubing8463540 09462025-03-18
00851978007665WoundPro+ Collection Canister8463540 09412025-03-18
00851978007672WoundPro+ 300cc Advanced Canister w/8' Tubing8463540 09462025-03-18
00851978007641MicroDoc NPWT System8463550 40172025-03-04
00851978007658MicroDoc NPWT System8463550 40072025-03-04
10851978007631WoundPro+ 300cc Advanced Canister w/5' Tubing8463540 09162025-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197998382895Solventum™ Veraflo™ Cleanse Choice™Solventum US LLCOMP2026-05-28
00849405002796Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002802Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002819Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002826Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002833Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002840Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00749756392495DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-01-22
00849405002673Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002680Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002697Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002703Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002710Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002727Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
08718104890947Endo-SPONGE PumpMeditop B.V.OMP2025-10-17
00197998028922Solventum US LLCKCI USA, INC.OMP2025-07-29
00197998028946Solventum US LLCKCI USA, INC.OMP2025-07-29
00197998032608Solventum US LLCKCI USA, INC.OMP2025-07-29
00197998312267Solventum US LLCKCI USA, INC.OMP2025-07-29
10851978007662WoundPro+ Collection CanisterPensar Medical, LLCOMP2025-03-18
10851978007679WoundPro+ 300cc Advanced Canister w/8' TubingPensar Medical, LLCOMP2025-03-18
10851978007631WoundPro+ 300cc Advanced Canister w/5' TubingPensar Medical, LLCOMP2025-01-14
07612367016940Invia Liberty Carrying CaseMedela AGOMP2024-10-11
07612367060509Invia Motion Carrying CaseMedela AGOMP2024-10-11
07612367038713Standard rail universal holderMedela AGOMP2024-06-03
00749756390194DeRoyalDEROYAL INDUSTRIES, INC.OMP2024-05-08
00749756390200DeRoyalDEROYAL INDUSTRIES, INC.OMP2024-05-08
00749756390217DeRoyalDEROYAL INDUSTRIES, INC.OMP2024-05-08
108495540138623M™ V.A.C.®KCI USA, INC.OMP2024-03-05