FDA.reportPublic FDA data

NEXA NPWT FLUID CONTAINER PACK

Primary DI
15060826400035
Brand
NEXA NPWT FLUID CONTAINER PACK
Company
NEXA MEDICAL LIMITED
Model
414-00-102
Device description
Nexa NPWT Fluid Container Pack is used as a disposable receptacle for wound fluid.
Published
2023-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
K162610000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162610000NEXA Negative Pressure Wound Therapy SystemNexa Medical , Ltd.2017-06-08OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060826400035PackageGS15In Commercial Distribution
35060826400039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506082640003515060826400035
3506082640003935060826400039

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system canisterA receptacle for the collection of excess interstitial fluid, exudate, and infectious materials from a dedicated dressing that has been applied for a vacuum-assisted wound closure procedure; commonly known as negative pressure wound therapy (NPWT). It is typically made of transparent disposable plastic materials and is connected to or placed into the NPWT system's vacuum pump. This receptacle is a single-use device that should be discarded, including its contaminated waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
221046947
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
25060826400056NEXA Drape414-00-6012023-08-30
25060826400063Nexa Foam414-00-7012023-08-30
35060826400015NEXA NPWT DRESSING -125mmHg414-00-1012023-08-30
35060826400039NEXA NPWT FLUID CONTAINER PACK414-00-1022023-08-30
15060826400004NEXA NPWT Device Kit414-00-3002023-08-30
15060826400059NEXA Drape414-00-6012023-08-30
15060826400066Nexa Foam414-00-7012023-08-30
15060826400011NEXA NPWT DRESSING -125mmHg414-00-1012023-08-30

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