FDA.reportPublic FDA data

Negative-pressure wound therapy system, line-powered

Definition
An assembly of devices designed to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps, and grafts with suction. It typically consists of a dressing (e.g., open-cell foam or medicated gauze), an airtight adhesive drape, an evacuation tube, a collection canister, and a mains electricity (AC-powered) computer-controlled vacuum pump. The pump applies continuous or intermittent negative pressure to the wound via the tube to the dressing which decompresses capillaries/lymphatic vessels, improves blood/interstitial fluid circulation, draws wound edges together, facilitates granulation tissue formation, and prepares the wound bed for closure.
GUDID devices
37
Last updated
2020-12-18 10:55:37

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08718104890459CC1 Wound Drainage pumpMeditop B.V.XL2020-12-10
08718104890466CCT Mini Wound Drainage pumpMeditop B.V.XS2020-12-10
50885380153042CARDINAL HEALTHCardinal Health 200, LLC48-00102018-05-30
00040565126470RenasysSMITH & NEPHEW MEDICAL LIMITED668013092016-09-20
08718104890022NEWERA II Wound Drainage PumpMeditop B.V.XS2016-10-26
08718104890039HALO MINI Wound Drainage PumpMeditop B.V.XS2016-10-26
08718104890046HALO XT Wound Drainage PumpMeditop B.V.XL2016-10-26
08718104890053NEWERA I Wound Drainage PumpMeditop B.V.XL2016-10-26
08718104890060RCI VAK Wound Drainage PumpMeditop B.V.XL2017-01-26
08718104890077JR VAK Wound Drainage PumpMeditop B.V.XS2017-01-26
87181048900084Exsudex Wound Drainage pumpMeditop B.V.XS2018-02-09
87181048900152Exsudex Wound Drainage PumpMeditop B.V.XL2018-02-09
87181048900220NEWERA II Wound Drainage PumpMeditop B.V.XS2018-02-09
87181048900398HALO MINI Wound Drainage PumpMeditop B.V.XS2018-02-09
87181048900466HALO XT Wound Drainage PumpMeditop B.V.XL2018-02-09
87181048900534NEWERA I Wound Drainage PumpMeditop B.V.XL2018-02-09
87181048900602RCI VAK Wound Drainage PumpMeditop B.V.XL2018-02-09
87181048900770JR VAK Wound Drainage PumpMeditop B.V.XS2018-02-09
07290111490002Vcare AlphaI.V.T. MEDICAL LTDVcare α® Device2017-08-13
07290111495007Vcare AlphaI.V.T. MEDICAL LTDProximal Tube2017-08-13
07290111495106Vcare AlphaI.V.T. MEDICAL LTDCollecting Canister2017-08-13
07290111495205Vcare AlphaI.V.T. MEDICAL LTDCollecting Canister + Proximal Tube2017-08-13
17290111491006Vcare AlphaI.V.T. MEDICAL LTDWound Dressing Kit 10x102017-08-13
17290111491105Vcare AlphaI.V.T. MEDICAL LTDWound Dressing Kit 10x202017-08-13
17290111491204Vcare AlphaI.V.T. MEDICAL LTDWound Dressing Kit 15x202017-08-13
17290111491303Vcare AlphaI.V.T. MEDICAL LTDWound Dressing Kit 20x302017-08-13
17290111491402Vcare AlphaI.V.T. MEDICAL LTDWoind Dressing Kit 40x452017-08-13
17290111492003Vcare AlphaI.V.T. MEDICAL LTDSponge Accessory Pack 10x102017-08-13
17290111492102Vcare AlphaI.V.T. MEDICAL LTDSponge Accessory Pack 10x202017-08-13
17290111492201Vcare AlphaI.V.T. MEDICAL LTDSponge Accessory Pack 15x202017-08-13
17290111492300Vcare AlphaI.V.T. MEDICAL LTDSponge Accessory Pack 20x302017-08-13
17290111492409Vcare AlphaI.V.T. MEDICAL LTDSponge Accessory Pack 40x452017-08-13
17290111493000Vcare AlphaI.V.T. MEDICAL LTDROI-NPT Wound Dressing Kit 20x302017-08-13
17290111493109Vcare AlphaI.V.T. MEDICAL LTDROI-NPT Wound Dressing Kit 40x452017-08-13
17290111494007Vcare AlphaI.V.T. MEDICAL LTDIrrigation hose adapter accessory kit2017-08-13
17290111494106Vcare AlphaI.V.T. MEDICAL LTDHose Adapter Accessory kit2017-08-13
17290111494205Vcare AlphaI.V.T. MEDICAL LTDDrape Accessory Pack2017-08-13