FDA.reportPublic FDA data

ExtriCARE

Primary DI
14897089070320
Brand
ExtriCARE
Company
ALLEVA MEDICAL LIMITED
Model
MI388-0001
Catalog number
EC1000
Device description
Extricare 1000 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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213906000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213906000extriCARE 1000 Negative Pressure Wound Therapy SystemAlleva Medical, Ltd.2023-03-08OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14897089070320PackageGS11In Commercial Distribution
24897089070327PackageGS14In Commercial Distribution
04897089070323PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1489708907032014897089070320
2489708907032724897089070327
04897089070323048970890703234897089070323

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
00197998382819Solventum™ Veraflo™ Cleanse Choice™Solventum US LLCOMP2026-05-28
00197998382895Solventum™ Veraflo™ Cleanse Choice™Solventum US LLCOMP2026-05-28
00849405002796Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002802Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002819Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002826Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002833Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002840Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00749756392495DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-01-22
00849405002673Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002680Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002697Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002703Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002710Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002727Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
08718104890947Endo-SPONGE PumpMeditop B.V.OMP2025-10-17
00197998028922Solventum US LLCKCI USA, INC.OMP2025-07-29
00197998028946Solventum US LLCKCI USA, INC.OMP2025-07-29
00197998032608Solventum US LLCKCI USA, INC.OMP2025-07-29
00197998312267Solventum US LLCKCI USA, INC.OMP2025-07-29
10851978007662WoundPro+ Collection CanisterPensar Medical, LLCOMP2025-03-18
10851978007679WoundPro+ 300cc Advanced Canister w/8' TubingPensar Medical, LLCOMP2025-03-18
10851978007631WoundPro+ 300cc Advanced Canister w/5' TubingPensar Medical, LLCOMP2025-01-14
07612367016940Invia Liberty Carrying CaseMedela AGOMP2024-10-11
07612367060509Invia Motion Carrying CaseMedela AGOMP2024-10-11
07612367038713Standard rail universal holderMedela AGOMP2024-06-03
00749756390194DeRoyalDEROYAL INDUSTRIES, INC.OMP2024-05-08
00749756390200DeRoyalDEROYAL INDUSTRIES, INC.OMP2024-05-08
00749756390217DeRoyalDEROYAL INDUSTRIES, INC.OMP2024-05-08
108495540138623M™ V.A.C.®KCI USA, INC.OMP2024-03-05