Identity
- Trade Name
- BioTab FDA UDI
- Generic Name
- Multi-chamber venous compression system garment, reusable FDA UDI
- Device Name
- BT Lymphedema Pump (PCB) 8 Chamber Replacement Sleeves (Medium Wide) FDA UDI
- Model / Reference
- RHB3023SLEMW FDA UDI
- Description
- BT Lymphedema Pump (PCB) 8 Chamber Replacement Sleeves (Medium Wide) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810113578255 FDA UDI
- FDA Product Code
- IRP FDA UDI
- GMDN Term
- Multi-chamber venous compression system garment, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multi-chamber venous compression system garment, reusable
BioTab by Vive Health Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Vive Health Llc
Sources (1)
- FDA UDI 00d9a980-f1b2-46d0-8822-f12dc29b5e3d 33 fields · synced May 30, 2026