FDA.reportPublic FDA data

Nisus NPWT Wound Kit

Primary DI
00851675007210
Brand
Nisus NPWT Wound Kit
Company
CORK MEDICAL, LLC
Model
WDK300T
Device description
Negative Pressure Wound Therapy Dressing, Wound Kit, WDK300T Wound Kit, Thick Foam with 1.2.3. Drape
Published
2016-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K132004000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132004000NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGECreo Quality, LLC2014-05-02OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851675007210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851675007210008516750072108516750072100851675007210

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system dressing setA collection of devices that composes a sterile dressing pack used with the pump and collection container of a negative pressure wound therapy (NPWT) system to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic) and diabetic/pressure ulcers. It typically includes dressing (e.g., open-cell foam or medicated gauze), an airtight adhesive drape, a drain, an evacuation tube, and sterile saline. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
015964214
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851675007388Nisus ONE NPWT System OCMPP-1002026-04-21
00851675007395100ml CanisterCPC-1002025-05-15
00851675007401VERSA NPWT SystemVCMPP-1002025-05-15
00851675007265Nisus Touch NPWT SystemTCMPP-1002022-12-19
00851675007005Nisus NPWT SystemCMPP-1002016-09-02
00851675007012Nisus NPWT Wound KitWDK-3002016-09-02
00851675007029Nisus NPWT Wound KitWDK-4002016-09-02
00851675007036Nisus NPWT AccessoryCWD-2002016-09-02
00851675007043Nisus NPWT AccessoryCWD-100-GS2016-09-02
00851675007050Nisus NPWT AccessoryCWF-100-ES-B2016-09-02
00851675007067Nisus NPWT AccessoryCWF-200-ES-B2016-09-02
00851675007074Nisus NPWT AccessoryCSP-100-ES-B2016-09-02
00851675007081Nisus NPWT AccessoryCSP-100-ES-EXT 2016-09-02
00851675007098Nisus NPWT SystemCPC-2502016-09-02
00851675007104Nisus NPWT SystemCPC-500 2016-09-02
00851675007128Nisus NPWT AccessoryCWY-1002016-09-02
00851675007135Nisus NPWT SystemNIS-CHRG-B-162016-09-02
00851675007203Nisus NPWT Wound KitFM-1.25-5-8-A-162016-11-09
00851675007227Nisus NPWT Wound KitWDK-2502016-11-09
00851675007159Elite Balance Air Mattress6406-5 2016-09-02

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