FDA.reportPublic FDA data

Aria AK Valve

Primary DI
00850013242115
Brand
Aria AK Valve
Company
CYPRESS ADAPTIVE, LLC
Model
CA100-AK
Catalog number
CA100-AK
Device description
Auto-Expulsion suction suspension valve for prosthetic sockets
Published
2019-12-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ISPValve, Prosthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISPValve, ProsthesisPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850013242115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850013242115008500132421158500132421150850013242115

GMDN Terms#

Term, Definition table
TermDefinition
Prosthesis suspension systemA group of devices used to hold/fasten a prosthesis to the body. The devices include locking pins, belts, silicone or neoprene sleeves, wedges, clamps, and suction sockets.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080277500
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850013242092Aria safety barb (US)CA300-ASBCA300-ASB2019-12-17
00850013242108Aria Safety Barb (metric)CA300-ASBMCA300-ASBM2019-12-17
00850013242894Aria Universal Mini Valve Molding DummyCA100-MVDCA100-MVD2023-10-05
00850013242887Aria Universal Mini Valve KeyCA100-MVK2022-10-01
00850013242016Aria Mini ValveCA100-MVCA100-MV2021-08-11
00085001342106Aria Mini ValveCA100-MVCA100-MV2021-08-11
00850013242009Aria Valve (US)CA200-AVCA200-AV2019-12-17
00850013242023Aria valve (metric)CA200-AVMCA200-AVM2019-12-17
00850013242030Aria Valve Plus (US)CA200-AVPCA200-AVP2019-12-17
00850013242047Aria valve plus (metric)CA200AVPMCA200AVPM2019-12-17
00850013242054Aria E-valveCA200-AECA200-AE2019-12-17
00850013242061Aria plate valveCA300-APVCA300-APV2019-12-17
00850013242078Aria HV Plate Valve CA300-AHVPCA300-AHVP2019-12-17
00850013242085Aria Hybrid ValveCA300-HYVCA300-HYV2019-12-17
00850013242122Aria AK valve insertCA100-VICA100-VI2019-12-17
00850013242139Cypress 4-hole tie-in plateCA400-TIPCA400-TIP2019-12-17
00850013242146Cypress low profile 4-hole tie-in plateCA400-LPCA400-LP2019-12-17
00850013242153Aria auto expulsion valve insertCA400-VCA400-V2019-12-17
00850013242160Aria HV Valve insert CA400-HVCA400-HV2019-12-17
00850013242177Aria 90 degree HV Valve Insert CA400-HV9CA400-HV92019-12-17

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Primary DI, Brand, Company table
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