Aria 90-degree HV valve insert kit

Basic Information

• Brand Name: Aria 90-degree HV valve insert kit
• Primary DI: 00850013242221
• Version / Model: CA400-TIP-HV9
• Catalog Number: CA400-TIP-HV9
• Company Name: CYPRESS ADAPTIVE, LLC
• Labeler DUNS: 080277500
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-17
• Public Version: 2
• Public Version Date: 2021-08-12
• Public Version Status: Update
• Public Device Record Key: 75efedae-23bb-417b-a3fd-a2118ecdd780

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ISP	Valve, Prosthesis	Physical Medicine	890.3420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64715	External lower-limb prosthesis suspensory component, non-powered	A non-powered device intended to be integrated in the socket shell of an external lower limb prosthesis to reduce the axial movement between the residual limb and the prosthesis, when the prosthesis is unloaded. It may be designed in various forms (e.g., strap, sleeve, cuff, thigh corset, shell, belt, pin, lock, valves).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850013242221	GS1