FDA.reportPublic FDA data

Negative-pressure wound therapy system, electric, single-use

Definition
A 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.
GUDID devices
122
Last updated
2026-10-04 01:48:00

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850084501920Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCHM30702026-09-24
00850084501937Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCHM30762026-09-24
00850084501944Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCHM30812026-09-24
00850084501951Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCHM30862026-09-24
00850084501005Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCproEWS2026-07-28
00850084501029Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLC2" Round2026-07-28
00850084501043Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLC1" x 3" Oblong2026-07-28
00850084501050Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLC3" x 5" Oblong2026-07-28
00850084501067Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCCanister2026-07-28
00849554004771PREVENA RESTOR ROTO•FORM™KCI USA, INC.PRE56552021-02-23
00849554006935PREVENA RESTOR™ ARTHRO•FORM™KCI USA, INC.PREVENA RESTOR™ ARTHRO•FORM™2019-03-04
00849554006959PREVENA RESTOR™ ARTHRO•FORM™KCI USA, INC.PREVENA RESTOR™ ARTHRO•FORM™2019-03-04
00849554007468PREVENA RESTOR™ BELLA•FORM™KCI USA, INC.PREVENA RESTOR™ BELLA•FORM™2019-04-23
00849554007475PREVENA RESTOR™ BELLA•FORM™KCI USA, INC.PREVENA RESTOR™ BELLA•FORM™2019-04-23
00849554007482PREVENA RESTOR™ BELLA•FORM™KCI USA, INC.PREVENA RESTOR™ BELLA•FORM™2019-04-23
00849554007857PREVENA RESTOR ROTO•FORM™KCI USA, INC.PRE56012021-02-23
00850590008227PWD™ Platform Wound Dressing Negative Pressure SysteMAPPLIED TISSUE TECHNOLOGIES LLC12025-11-20
00850590008241PWD™ Platform Wound Dressing Negative Pressure SystemAPPLIED TISSUE TECHNOLOGIES LLC12025-11-20
00850590008265PWD™ Platform Wound Dressing Negative Pressure SystemAPPLIED TISSUE TECHNOLOGIES LLC12025-11-20
05000223476793PICOSMITH & NEPHEW MEDICAL LIMITED668009552016-09-20
05000223477073PICOSMITH & NEPHEW MEDICAL LIMITED668009512016-09-20
05000223477134PICOSMITH & NEPHEW MEDICAL LIMITED668009542016-09-20
05000223477165PICOSMITH & NEPHEW MEDICAL LIMITED668009562016-09-20
05000223477189PICOSMITH & NEPHEW MEDICAL LIMITED668009572016-09-20
05000223477202PICOSMITH & NEPHEW MEDICAL LIMITED668009582016-09-20
05000223494643PICOSMITH & NEPHEW MEDICAL LIMITED660220222018-08-23
05000223494650PICOSMITH & NEPHEW MEDICAL LIMITED660220232018-08-23
05000223494667PICOSMITH & NEPHEW MEDICAL LIMITED660220242018-08-23
05000223494674PICOSMITH & NEPHEW MEDICAL LIMITED660220252018-08-23
05000223494681PICOSMITH & NEPHEW MEDICAL LIMITED660220262018-08-23
05000223494698PICOSMITH & NEPHEW MEDICAL LIMITED660220272018-08-23
05000223494704PICOSMITH & NEPHEW MEDICAL LIMITED660220282018-08-23
05000223494711PICOSMITH & NEPHEW MEDICAL LIMITED660220292018-08-23
05000223494728PICOSMITH & NEPHEW MEDICAL LIMITED660220202018-08-23
05000223494735PICOSMITH & NEPHEW MEDICAL LIMITED660220212018-08-23
07323190296705Avance® SoloMölnlycke Health Care AB88800502022-01-31
07323190297832Avance® SoloMölnlycke Health Care AB88810202022-01-31
07323190297863Avance® SoloMölnlycke Health Care AB88810302022-01-31
07323190297894Avance® SoloMölnlycke Health Care AB88810352022-01-31
07333350078478Avance® SoloMölnlycke Health Care AB88810302023-08-18
07333350692650Avance® SoloMölnlycke Health Care AB88810352023-05-22
07333350856069Avance® SoloMölnlycke Health Care AB88810202023-05-22
07333350965044Avance®Mölnlycke Health Care AB8900032024-10-31
10851978007464MicroDoc NPWT Control UnitPensar Medical, LLC8463550 10032022-10-12
00850590008203PWD™ Platform Wound Dressing Negative Pressure SysteAPPLIED TISSUE TECHNOLOGIES LLC12025-11-20
00850590008210PWD™ Platform Wound Dressing Negative Pressure SysteMAPPLIED TISSUE TECHNOLOGIES LLC12025-11-20
00850590008234PWD™ Platform Wound Dressing Negative Pressure SystemAPPLIED TISSUE TECHNOLOGIES LLC12025-11-20
00850590008258PWD™ Platform Wound Dressing Negative Pressure SystemAPPLIED TISSUE TECHNOLOGIES LLC12025-11-20
00851978007689MicroDoc NPWT SystemPensar Medical, LLC8463550 50042025-03-19
00851978007696MicroDoc NPWT SystemPensar Medical, LLC8463550 50012025-03-19
00851978007702MicroDoc NPWT SystemPensar Medical, LLC8463550 50022025-03-19
00851978007719MicroDoc NPWT SystemPensar Medical, LLC8463550 50062025-03-19
00851978007726MicroDoc NPWT SystemPensar Medical, LLC8463550 50032025-03-19
00851978007733MicroDoc NPWT SystemPensar Medical, LLC8463550 50072025-03-19
00851978007740MicroDoc NPWT SystemPensar Medical, LLC8463550 50112025-03-19
00851978007757MicroDoc NPWT SystemPensar Medical, LLC8463550 50142025-03-19
00851978007764MicroDoc NPWT SystemPensar Medical, LLC8463550 50122025-03-19
00851978007771MicroDoc NPWT SystemPensar Medical, LLC8463550 50162025-03-19
00851978007788MicroDoc NPWT SystemPensar Medical, LLC8463550 50132025-03-19
00851978007795MicroDoc NPWT SystemPensar Medical, LLC8463550 50172025-03-19
00851978007641MicroDoc NPWT SystemPensar Medical, LLC8463550 40172025-03-04
00851978007658MicroDoc NPWT SystemPensar Medical, LLC8463550 40072025-03-04
07333350648312Avance®Mölnlycke Health Care AB8900032024-10-31
00851978007603MicroDoc NPWT SystemPensar Medical, LLC8463550 40162024-10-23
00851978007610MicroDoc NPWT SystemPensar Medical, LLC8463550 40062024-10-23
00851978007580MicroDoc NPWT SystemPensar Medical, LLC8463550 40052024-09-12
00851978007597MicroDoc NPWT SystemPensar Medical, LLC8463550 40152024-09-12
00851978007559MicroDoc NPWT SystemPensar Medical, LLC8463550 40122024-08-12
00851978007566MicroDoc NPWT SystemPensar Medical, LLC8463550 40132024-08-12
00851978007573MicroDoc NPWT SystemPensar Medical, LLC8463550 40142024-08-12
00851978007542MicroDoc NPWT SystemPensar Medical, LLC8463550 40112024-07-30
00851978007528MicroDoc NPWT SystemPensar Medical, LLC8463550 40032024-07-29
00851978007535MicroDoc NPWT SystemPensar Medical, LLC8463550 40042024-07-29
00851978007504MicroDoc NPWT SystemPensar Medical, LLC8463550 40012024-06-17
00851978007511MicroDoc NPWT SystemPensar Medical, LLC8463550 40022024-06-17
07333350269326Avance® SoloMölnlycke Health Care AB88810302023-08-18
00849405000532UNO 15 Therapy Kit 10x10GENADYNE BIOTECHNOLOGIES INC.U-S1010-52023-06-09
00849405000549UNO 7 Therapy Kit 10x10GENADYNE BIOTECHNOLOGIES INC.U-S1010-42023-06-09
00849405001478UNO 30 Therapy Kit 10x10GENADYNE BIOTECHNOLOGIES INC.U-S1010-62023-06-09
00849405001607UNO Pump 7 Day RechargeableGENADYNE BIOTECHNOLOGIES INC.U-S00R42023-06-09