Identity
- Trade Name
- Therm-X FDA UDI
- Generic Name
- Inflatable hot/cold therapy pack/electric pump FDA UDI
- Device Name
- Therm-X Split Hose EUDAMED
- Model / Reference
- TX0208 EUDAMEDTherm-X Split Umbilical Hose FDA UDI
Identifiers
- Catalog Number
- TX0208 FDA UDI
- Primary DI / UDI-DI
- 00850001096478 EUDAMED00850001096164 FDA UDI
- Basic UDI-DI
- 08500010960208BQ EUDAMED
- Direct Marketing DI
- 00850001096478 EUDAMED
- FDA Product Code
- JOW FDA UDIILO FDA UDIIRP FDA UDI
- EMDN Code
- Z120616 ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY EUDAMED
- GMDN Term
- Inflatable hot/cold therapy pack/electric pump FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.5800 FDA UDI890.5720 FDA UDI890.5650 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Therm-X Split Hose by Zenith Technical Innovations, LLC. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08500010960208BQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zenith Technical Innovations, LLC.
- EUDAMED SRN
- US-MF-000047832
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED e81251db-1406-4d2a-b17a-48cfb77c3a4e 61 fields · synced Jun 18, 2026
- FDA UDI cf75588e-d1d5-491f-92d0-6beb348b40cf 33 fields · synced May 29, 2026