FDA.reportPublic FDA data

ExtriCARE

Primary DI
14897089070146
Brand
ExtriCARE
Company
ALLEVA MEDICAL LIMITED
Model
ST396-0001
Catalog number
EC-FOAM-S-E
Device description
Extricare Small Foam Dressing
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
true
Single use
true

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
K140634000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140634000extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing KitDevon Medical, Inc.2014-09-19OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14897089070146PackageGS115In Commercial Distribution
04897089070149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1489708907014614897089070146
04897089070149048970890701494897089070149

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system foam dressing, non-antimicrobialA pad made of open-cell foam material designed to be placed into a wound during a vacuum-assisted wound closure procedure, commonly known as negative pressure wound therapy (NPWT); it does not include an antimicrobial agent(s). It is typically used to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts. Under NPWT, the open-cell foam dressing decompresses capillaries/lymphatic vessels, improves blood/interstitial fluid circulation, draws wound edges together, facilitates granulation tissue formation, and prepares the wound bed for closure. It may be cut to conform to the wound. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

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
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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
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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
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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
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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