FDA.reportPublic FDA data

Avance Flex Negative Pressure Wound Therapy Canister, 300ML

Primary DI
00860385000824
Brand
Avance Flex Negative Pressure Wound Therapy Canister, 300ML
Company
APRIA HEALTHCARE LLC
Model
APR300
Device description
300ml Avance Flex Canister for use with the Avance Flex Negative Pressure Wound Therapy Pump
Published
2018-03-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
10860385000821PackageGS110Not in Commercial Distribution
00860385000824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086038500082110860385000821
00860385000824008603850008248603850008240860385000824

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).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume300Milliliter

Contacts#

Phone, Email table
PhoneEmail
949-639-2145alison.baxter@apria.com

Regulatory Flags#

DUNS number
198427874
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860385000855Avance Flex 2.0 Negative Pressure Wound Therapy PumpAPR1002018-05-01
10860385000821Avance Flex Negative Pressure Wound Therapy Canister, 300MLAPR3002018-03-23

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