Identity
- Trade Name
- Flexitouch FDA UDI
- Generic Name
- Multi-chamber venous compression system garment, reusable FDA UDI
- Model / Reference
- L-CF-RG-R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816305020144 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
Flexitouch is a multi-chamber venous compression system garment designed to promote venous blood flow and help treat or prevent conditions such as oedema, deep vein thrombosis (DVT), and pulmonary embolism (PE) in non-ambulatory patients or those at risk. This reusable device is applied externally to the limbs through sequential inflation of chambers, providing increased venous blood flow.
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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 fbb04215-76ce-47d4-b2d2-77ac903a976b 32 fields · synced Jul 24, 2026