Identity
- Trade Name
- One Degree Medical FDA UDI
- Generic Name
- Surgical fluid heating plate FDA UDI
- Device Name
- 3.8L Capacity Fluid Warming Unit - ODM-3038 FDA UDI
- Model / Reference
- ODM-3038 FDA UDI
- Description
- 3.8L Capacity Fluid Warming Unit - ODM-3038 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860003583050 FDA UDI
- FDA Product Code
- LHC FDA UDI
- GMDN Term
- Surgical fluid heating plate FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5950 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical fluid heating plate
One Degree Medical by One Degree Medical Holdings, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical fluid heating plate.
- Halyard — Avanos Medical, Inc. · Class I
- Halyard — Avanos Medical, Inc. · Class I
- One Degree Medical — ONE DEGREE MEDICAL HOLDINGS, LLC · 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 I | Pending data |
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Manufacturer
- Manufacturer
- One Degree Medical Holdings, Llc
Sources (1)
- FDA UDI 401425f7-aecb-4cdc-a7a7-567c5c034390 33 fields · synced Jun 6, 2026