Identity
- Trade Name
- Albahealth FDA UDI
- Generic Name
- Multi-chamber venous compression system garment, single-use FDA UDI
- Device Name
- LEGACY LOGIX CALF SLEEVE REGUL FDA UDI
- Model / Reference
- 0LL500012100304 FDA UDI
- Description
- LEGACY LOGIX CALF SLEEVE REGUL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00073614776999 FDA UDI
- 510(k) Number
- K123308 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
No
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
No
FDA UDI
Category: Multi-chamber venous compression system garment, single-use
Albahealth by Albahealth, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-chamber venous compression system garment, single-use.
- Kendall SCD — Cardinalhealth · Class II
- The Venous Assist System(DVT-2600) — DAESUNG MAREF CO., LTD. · Class II
- Kendall SCD — Cardinal Health 200, LLC · Class II
- VasoGrad — Compression Therapy Concepts · Class II
- A-V Impulse — Cardinalhealth · Class II
- The Venous Assist System — DAESUNG MAREF CO., LTD. · Class II
- Kendall SCD — Cardinalhealth · Class II
- VasoGrad — Compression Therapy Concepts · Class II
Cleared under the same submission
K123308 also covers:
- Albahealth — Albahealth, LLC
- Albahealth — Albahealth, LLC
- Albahealth — Albahealth, LLC
- Albahealth — Albahealth, LLC
- Albahealth — Albahealth, LLC
- Albahealth — Albahealth, LLC
- Albahealth — Albahealth, LLC
- Albahealth — Albahealth, LLC
- Albahealth — Albahealth, LLC
- Albahealth — Albahealth, LLC
- Albahealth — Albahealth, LLC
- Albahealth — Albahealth, LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Albahealth, LLC
Sources (1)
- FDA UDI a0baf0a5-6662-45a6-b276-2dfe549c66fa 34 fields · synced Jun 1, 2026