FDA.reportPublic FDA data

Avance Flex 2.0 Negative Pressure Wound Therapy Pump

Primary DI
00860385000855
Brand
Avance Flex 2.0 Negative Pressure Wound Therapy Pump
Company
APRIA HEALTHCARE LLC
Model
APR100
Device description
Avance Flex Pump
Published
2018-05-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00860385000800PackageGS11In Commercial Distribution
00860385000855PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860385000800008603850008008603850008000860385000800
00860385000855008603850008558603850008550860385000855

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system pump, electricA mains electricity (AC-powered) device intended to create and control negative pressure in a vacuum-assisted wound closure system during negative pressure wound therapy (NPWT) for the treatment of hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts. It is typically a computer-controlled vacuum pump with controls and display for continuous or intermittent negative pressure delivered through a tubing set to the open-cell foam dressing located at the airtight-sealed wound. It typically has internal batteries that allow the device to operate for a short period without line power (e.g., during transport or a power outage).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
198427874
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860385000824Avance Flex Negative Pressure Wound Therapy Canister, 300MLAPR3002018-03-23
10860385000821Avance Flex Negative Pressure Wound Therapy Canister, 300MLAPR3002018-03-23

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