Identity
- Trade Name
- DONJOY FDA UDI
- Generic Name
- Circulating-fluid localized thermal therapy system control unit FDA UDI
- Device Name
- VersaROM Hip + Cold Therapy Combo Kit FDA UDI
- Model / Reference
- 11-3334 FDA UDI
- Description
- VersaROM Hip + Cold Therapy Combo Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190446665175 FDA UDI
- FDA Product Code
- ILO FDA UDI
- GMDN Term
- Circulating-fluid localized thermal therapy system control unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5720 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Circulating-fluid localized thermal therapy system control unitHip orthosis
Donjoy by Djo, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hip orthosis.
- MECRON Hip-Spica U: 95-115 cm — Darco (Europe) GmbH · Class I
- MECRON Hip-Spica U: 95-115 cm — Darco (Europe) GmbH · Class I
- MECRON Hip-Compression U: 105-125 cm — Darco (Europe) GmbH · Class I
- ManaMed Inc — MANAMED LLC · Class I
- Vive — VIVE HEALTH LLC · Class I
- Vive — VIVE HEALTH LLC · Class I
- MECRON Hip-Compression U: 105-125 cm — Darco (Europe) GmbH · Class I
- MECRON Hip-Spica U: 95-115 cm — Darco (Europe) GmbH · Class I
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
- Djo, Llc
Sources (1)
- FDA UDI db39f9b1-cc51-4874-a057-cabb4d868d7f 33 fields · synced May 30, 2026