Aria 90-degree HV valve insert kit CA400-TIP-HV9

GUDID 00850013242221

Cypress 4 hole plate 90-degree valve insert to be used in prosthetic socket for elevated vacuum

CYPRESS ADAPTIVE, LLC

Prosthesis suspension system External lower-limb prosthesis suspensory component, non-powered External lower-limb prosthesis suspensory component, non-powered External lower-limb prosthesis suspensory component, non-powered External lower-limb prosthesis suspensory component, non-powered External lower-limb prosthesis suspensory component, non-powered External lower-limb prosthesis suspensory component, non-powered External lower-limb prosthesis suspensory component, non-powered External lower-limb prosthesis suspensory component, non-powered

• Primary Device ID: 00850013242221
• NIH Device Record Key: 75efedae-23bb-417b-a3fd-a2118ecdd780
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aria 90-degree HV valve insert kit
• Version Model Number: CA400-TIP-HV9
• Catalog Number: CA400-TIP-HV9
• Company DUNS: 080277500
• Company Name: CYPRESS ADAPTIVE, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850013242221 [Primary]

FDA Product Code

• ISP: Valve, Prosthesis

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-25
• Device Publish Date: 2019-12-17

Devices Manufactured by CYPRESS ADAPTIVE, LLC

• 00850013242894 - Aria Universal Mini Valve Molding Dummy: 2023-10-13 Molding dummy is used to install the Aria Universal Mini Valve in a prosthesis socket
• 00850013242887 - Aria Universal Mini Valve Key: 2022-10-10 Tool to install or remove valves for prosthesis sockets
• 00850013242016 - Aria Mini Valve: 2021-11-25 Valve for installation into limb prosthesis with a small diameter and low profile.
• 00085001342106 - Aria Mini Valve: 2021-08-19 Valve for installation into limb prosthesis with a small diameter and low profile.
• 00850013242009 - Aria Valve (US): 2019-12-25 Auto Expulsion suction valve (US threads) for prosthetic sockets
• 00850013242023 - Aria valve (metric): 2019-12-25 Aria valve (metric threads) auto expulsion suction valve for prosthetic sockets.
• 00850013242030 - Aria Valve Plus (US): 2019-12-25 Aria valve plus auto-expulsion valve for installation in lower-limb prosthesis sockets for suction suspension.
• 00850013242047 - Aria valve plus (metric): 2019-12-25 Aria valve (metric) auto expulsion suction valve for prosthetic sockets.