Identity
- Trade Name
- AIROS FDA UDI
- Generic Name
- Multi-chamber venous compression system garment, single-use FDA UDI
- Device Name
- AIROS Arm Plus Expander (Left) FDA UDI
- Model / Reference
- APXLL01 FDA UDI
- Description
- AIROS Arm Plus Expander (Left) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850031012554 FDA UDI
- FDA Product Code
- JOW FDA UDI
- GMDN Term
- Multi-chamber venous compression system garment, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 80 Centimeter FDA UDI
Category: Multi-chamber venous compression system garment, single-use
Airos by Airos Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multi-chamber venous compression system garment, single-use.
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- VasoGrad — Compression Therapy Concepts · Class II
- A-V Impulse — Cardinalhealth · Class II
- Albahealth — Albahealth, LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Airos Medical Inc
Sources (1)
- FDA UDI 30b825e1-428f-45a8-8531-819ab0927fa9 35 fields · synced Jun 8, 2026