Identity
- Trade Name
- Flexitouch FDA UDI
- Generic Name
- Multi-chamber venous compression system garment, reusable FDA UDI
- Model / Reference
- U-AS-S3-R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816305020489 FDA UDI
- FDA Product Code
- JOW FDA UDI
- GMDN Term
- Multi-chamber venous compression system garment, reusable 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
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Multi-chamber venous compression system garment, reusable
Unlock the benefits of venous blood flow with Flexitouch, a cutting-edge inflatable device designed to promote circulation in non-ambulatory patients and at-risk individuals. This reusable Multi-chamber venous compression system garment is applied externally to the limbs through sequential inflation, helping to prevent conditions such as oedema, DVT, and PE.
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Authorization Coverage (1 country)
Regulatory Authorizations
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
- Tactile Systems Technology Inc
Sources (1)
- FDA UDI 75cc1d25-460e-4592-a017-947c2269a91f 32 fields · synced Jul 1, 2026