FDA.reportPublic FDA data

MicroDoc NPWT System

Primary DI
00851978007764
Brand
MicroDoc NPWT System
Company
Pensar Medical, LLC
Model
8463550 5012
Device description
MicroDoc NPWT ComforTech+ Dressing, 10cm x 20cm (5cm x 15cm)
Published
2025-03-19
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
K200223000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200223000PocketDoc™ Micro Wound Therapy SystemPensar Medical, LLC2020-10-23OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851978007764PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851978007764008519780077648519780077640851978007764

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system, electric, single-useA portable assembly of devices designed to apply suction to help heal traumatic and chronic skin wounds (e.g., grafts, incisions, burns, ulcers) with low to moderate levels of exudate. It typically consists of an electrically-powered vacuum pump, a highly-absorbent wound dressing and/or collection canister to contain the exudate, and a connection tube. The pump applies continuous or intermittent negative pressure to the wound via the tube/dressing to decompress capillaries/lymphatic vessels, improve blood/interstitial fluid circulation, draw wound edges together, facilitate granulation tissue formation, and prepare the wound bed for closure. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
079262228
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
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
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
01085197800762WoundPro+ Collection Canister8463540 09212025-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756402316DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-10-16
00749756402323DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-10-16
00749756402330DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-10-16
00749756402347DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-10-16
00749756402354DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-10-16
00749756402361DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-10-16
00749756402378DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-10-16
00850084501920Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-09-24
00850084501937Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-09-24
00850084501944Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-09-24
00850084501951Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-09-24
00749756369640DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-23
00749756985475DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-21
00749756985963DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-21
00749756985994DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-21
00749756986250DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-21
00749756401289DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-18
00749756401692DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-18
00749756401746DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-18
04719873697724NACARILEX MEDICAL, INC.OMP2026-08-26
04719873697731NACARILEX MEDICAL, INC.OMP2026-08-26
04719873697748NACARILEX MEDICAL, INC.OMP2026-08-26
04719873697755NACARILEX MEDICAL, INC.OMP2026-08-26
04719873697762NACARILEX MEDICAL, INC.OMP2026-08-26
00197998301209Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-08-07
00197998301285Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-08-07
00197998301360Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-08-07
00850084501005Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501029Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501036Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28