FDA.reportPublic FDA data

ExtriCARE

Primary DI
14897089070788
Brand
ExtriCARE
Company
ALLEVA MEDICAL LIMITED
Model
MI391-0002
Catalog number
EC3000
Device description
ExtriCARE 3000 Negative Pressure Wound Therapy Pump
Published
2023-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14897089070788PackageGS11In Commercial Distribution
24897089070785PackageGS14In Commercial Distribution
04897089070781PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1489708907078814897089070788
2489708907078524897089070785
04897089070781048970890707814897089070781

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system, electric, reusableAn 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 an electrically-powered 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. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
669361099
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04897089070088ExtriCAREST390-0002EC2400-MN-E2026-03-05
04897089070101ExtriCAREST392-00022026-03-05
14897089070085ExtriCAREST390-0002EC2400-MN-E2026-03-05
14897089070108ExtriCAREST392-00022026-03-05
04897089070682ExtriCAREST407-0005EC-FOAM-M-E2026-03-02
04897089070330ExtricareST396-0003EC-FOAM-S-F2026-03-02
04897089070446ExtricareST407-0003EC-FOAM-M-F2026-03-02
14897089070689ExtriCAREST407-0005EC-FOAM-M-E2026-03-02
04897089070019PlexusRP100MI329-00012026-01-14
14897089070016PlexusRP100MI329-00012026-01-14
04897089070163ExtriCARE EC-DOMEST4012025-12-03
04897089070200ExtricareST404-0001EC2400-Y-E2025-12-03
14897089070160ExtriCARE EC-DOMEST4012025-12-03
14897089070207ExtricareST404-0001EC2400-Y-E2025-12-03
04897089070996VideST425-00012025-11-03
04897089071498VideST424-0001ST424-00012025-11-03
04897089070217ExtriCAREST403-0001EC-DRAPE2023-12-28
04897089070361ExtriCAREMI423-0001EC3000-100C2023-12-28
04897089070378ExtriCAREMI424-0001EC3000-400C2023-12-28
04897089070477ExtriCAREMI425-0001EC1000-CAN2023-12-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850084501043Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501050Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501067Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00197998301148Solventum™ ActiV.A.C.™KCI USA, INC.OMP2026-07-23
00197998301162Solventum™ ActiV.A.C.™KCI USA, INC.OMP2026-07-23
00197998303906Solventum™ ActiV.A.C.™KCI USA, INC.OMP2026-07-23
00197998276507Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22