Identity
- Trade Name
- ThermaZone FDA UDI
- Generic Name
- Medical device service rail clamp FDA UDI
- Device Name
- ThermaZone Hospital Bed Bracket. This device can attach directly to the patient's bed or to the ThermaZone IV pole with base. FDA UDI
- Model / Reference
- 003-79 FDA UDI
- Description
- ThermaZone Hospital Bed Bracket. This device can attach directly to the patient's bed or to the ThermaZone IV pole with base. FDA UDI
Identifiers
- Catalog Number
- 003-79 FDA UDI
- Primary DI / UDI-DI
- 00854682001547 FDA UDI
- FDA Product Code
- ILO FDA UDI
- GMDN Term
- Medical device service rail clamp 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
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: Medical device service rail clamp
ThermaZone by Innovative Medical Equipment — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Medical device service rail clamp.
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- Bracket — LivaNova USA, Inc. · Class I
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class I
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class I
- CAPIOX — Terumo Corp. · 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 |
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Manufacturer
- Manufacturer
- Innovative Medical Equipment
Sources (1)
- FDA UDI 61786f9f-15a0-4c70-a227-cbae7ae33aae 36 fields · synced Jun 1, 2026