FDA.reportPublic FDA data

Negative-pressure wound therapy system, battery-powered, 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 a non-sterile battery-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
105
Last updated
2021-03-03 07:39:31

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00849554007864PREVENA RESTOR ROTO•FORM™KCI USA, INC.PRE56552021-02-23
50849554007852PREVENA RESTOR ROTO•FORM™KCI USA, INC.PRE56012021-02-23
00630414954172IMMULITE®/IMMULITE® 1000 Systems PRL Prolactin Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD103870402020-09-24
05000223495381Pico 14SMITH & NEPHEW MEDICAL LIMITED660220422019-12-19
05000223495398Pico 14SMITH & NEPHEW MEDICAL LIMITED660220432019-12-19
05000223495404Pico 14SMITH & NEPHEW MEDICAL LIMITED660220442019-12-19
05000223495411Pico 14SMITH & NEPHEW MEDICAL LIMITED660220452019-12-19
05000223495428Pico 14SMITH & NEPHEW MEDICAL LIMITED660220462019-12-19
05000223495435Pico 14SMITH & NEPHEW MEDICAL LIMITED660220472019-12-19
05000223495442Pico 14SMITH & NEPHEW MEDICAL LIMITED660220482019-12-19
05000223495459Pico 14SMITH & NEPHEW MEDICAL LIMITED660220492019-12-19
05000223495466Pico 14SMITH & NEPHEW MEDICAL LIMITED660220402019-12-19
05000223495473Pico 14SMITH & NEPHEW MEDICAL LIMITED660220412019-12-19
00849554007826PREVENA RESTOR AXIO•FORM™KCI USA, INC.PRE55012019-12-19
00849554007949PREVENA RESTOR AXIO•FORM™KCI USA, INC.PRE55552019-12-19
00849554007819PREVENA PLUS™KCI USA, INC.PRE40102019-11-28
00849554007123PREVENA RESTOR™ BELLA•FORM™KCI USA, INC.PREVENA RESTOR™ BELLA•FORM™2019-04-23
00849554007130PREVENA RESTOR™ BELLA•FORM™KCI USA, INC.PRE54552019-04-23
00849554007147PREVENA RESTOR™ BELLA•FORM™KCI USA, INC.PREVENA RESTOR™ BELLA•FORM™2019-04-23
00849554007154PREVENA RESTOR™ BELLA•FORM™KCI USA, INC.PRE52552019-04-23
00849554007161PREVENA RESTOR™ BELLA•FORM™KCI USA, INC.PREVENA RESTOR™ BELLA•FORM™2019-04-23
00849554007178PREVENA RESTOR™ BELLA•FORM™KCI USA, INC.PRE53552019-04-23
05000223477080PICOSMITH & NEPHEW MEDICAL LIMITED668009512016-09-20
05000223477097PICOSMITH & NEPHEW MEDICAL LIMITED668009522016-09-20
05000223477110PICOSMITH & NEPHEW MEDICAL LIMITED668009532016-09-20
05000223477141PICOSMITH & NEPHEW MEDICAL LIMITED668009542016-09-20
05000223477158PICOSMITH & NEPHEW MEDICAL LIMITED668009552016-09-20
05000223477172PICOSMITH & NEPHEW MEDICAL LIMITED668009562016-09-20
05000223477196PICOSMITH & NEPHEW MEDICAL LIMITED668009572016-09-20
05000223477219PICOSMITH & NEPHEW MEDICAL LIMITED668009582016-09-20
05000223491017PICOSMITH & NEPHEW MEDICAL LIMITED660213582017-09-22
05000223491024PICOSMITH & NEPHEW MEDICAL LIMITED660213592017-09-22
05000223491031PICOSMITH & NEPHEW MEDICAL LIMITED660213602017-09-22
05000223491048PICOSMITH & NEPHEW MEDICAL LIMITED660213612017-09-22
05000223491055PICOSMITH & NEPHEW MEDICAL LIMITED660213622017-09-22
05000223491062PICOSMITH & NEPHEW MEDICAL LIMITED660213632017-09-22
05000223491079PICOSMITH & NEPHEW MEDICAL LIMITED660213642017-09-22
05000223491086PICOSMITH & NEPHEW MEDICAL LIMITED660213652017-09-22
05000223491093PICO™ MULTISITE 15x20cmSMITH & NEPHEW MEDICAL LIMITED660213562017-06-09
05000223491109PICO™ MULTISITE 20x25cmSMITH & NEPHEW MEDICAL LIMITED660213572017-06-09
05000223492076PICO™ 7SMITH & NEPHEW MEDICAL LIMITED660220222018-08-23
05000223492175PICOSMITH & NEPHEW MEDICAL LIMITED660220022018-08-23
05000223492182PICOSMITH & NEPHEW MEDICAL LIMITED660220032018-08-23
05000223492199PICOSMITH & NEPHEW MEDICAL LIMITED660220042018-08-23
05000223492205PICOSMITH & NEPHEW MEDICAL LIMITED660220052018-08-23
05000223492212PICOSMITH & NEPHEW MEDICAL LIMITED660220062018-08-23
05000223492229PICOSMITH & NEPHEW MEDICAL LIMITED660220072018-08-23
05000223492236PICOSMITH & NEPHEW MEDICAL LIMITED660220082018-08-23
05000223492243PICOSMITH & NEPHEW MEDICAL LIMITED660220092018-08-23
05000223492250PICOSMITH & NEPHEW MEDICAL LIMITED660220002018-08-23
05000223492267PICOSMITH & NEPHEW MEDICAL LIMITED660220012018-08-23
05000223492373PICOSMITH & NEPHEW MEDICAL LIMITED660220122018-08-23
05000223492380PICOSMITH & NEPHEW MEDICAL LIMITED660220132018-08-23
05000223492397PICOSMITH & NEPHEW MEDICAL LIMITED660220142018-08-23
05000223492403PICOSMITH & NEPHEW MEDICAL LIMITED660220152018-08-23
05000223492410PICOSMITH & NEPHEW MEDICAL LIMITED660220162018-08-23
05000223492427PICOSMITH & NEPHEW MEDICAL LIMITED660220172018-08-23
05000223492434PICOSMITH & NEPHEW MEDICAL LIMITED660220182018-08-23
05000223492441PICOSMITH & NEPHEW MEDICAL LIMITED660220192018-08-23
05000223492458PICOSMITH & NEPHEW MEDICAL LIMITED660220102018-08-23
05000223492465PICOSMITH & NEPHEW MEDICAL LIMITED660220112018-08-23
05000223492571PICO™ 7SMITH & NEPHEW MEDICAL LIMITED660220232018-08-23
05000223492588PICO™ 7SMITH & NEPHEW MEDICAL LIMITED660220242018-08-23
05000223492595PICO™ 7SMITH & NEPHEW MEDICAL LIMITED660220252018-08-23
05000223492601PICO™ 7SMITH & NEPHEW MEDICAL LIMITED660220262018-08-23
05000223492618PICO™ 7SMITH & NEPHEW MEDICAL LIMITED660220272018-08-23
05000223492625PICO™ 7SMITH & NEPHEW MEDICAL LIMITED660220282018-08-23
05000223492632PICO™ 7SMITH & NEPHEW MEDICAL LIMITED660220292018-08-23
05000223492649PICO™ 7SMITH & NEPHEW MEDICAL LIMITED660220202018-08-23
05000223492656PICO™ 7SMITH & NEPHEW MEDICAL LIMITED660220212018-08-23
05000223493929PICOSMITH & NEPHEW MEDICAL LIMITED660020022018-11-27
05000223493936PICOSMITH & NEPHEW MEDICAL LIMITED660020032018-11-27
05000223493943PICOSMITH & NEPHEW MEDICAL LIMITED660020042018-11-27
05000223493950PICOSMITH & NEPHEW MEDICAL LIMITED660020052018-11-27
05000223493967PICOSMITH & NEPHEW MEDICAL LIMITED660020062018-11-27
05000223493974PICOSMITH & NEPHEW MEDICAL LIMITED660020072018-11-27
05000223493981PICOSMITH & NEPHEW MEDICAL LIMITED660020082018-11-27
05000223493998PICOSMITH & NEPHEW MEDICAL LIMITED660020092018-11-27
05000223494001PICOSMITH & NEPHEW MEDICAL LIMITED660020002018-11-27
05000223494018PICOSMITH & NEPHEW MEDICAL LIMITED660020012018-11-27