FDA UDI
In Commercial Distribution
🇺🇸 United States
Aria expulsion valve and plug kit
DI: 00850013242252
·
Model: CA400-TIP-VK
·
CYPRESS ADAPTIVE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Aria expulsion valve and plug kit
- Primary DI
- 00850013242252
- Version / Model
- CA400-TIP-VK
- Catalog Number
- CA400-TIP-VK
- 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
- 361e475b-fd66-49b5-b374-f6b5a16ff213
Device Description
Cypress 4 hole Plate expulsion valve solid plug insert with insert tool for installation into prosthetic sockets
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 | 00850013242252 | GS1 |