Identity
- Trade Name
- Tempus IC2 FDA UDI
- Generic Name
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
- Device Name
- Tempus IC2 Patient Monitor FDA UDI
- Model / Reference
- 00-2001-R FDA UDI
- Description
- Tempus IC2 Patient Monitor FDA UDI
Identifiers
- Catalog Number
- 867374 FDA UDI
- Primary DI / UDI-DI
- 05060472442949 FDA UDI
- FDA Product Code
- MWI FDA UDI
- GMDN Term
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2300 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Tempus IC2 by Remote Diagnostic Technologies Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Remote Diagnostic Technologies Limited
Sources (1)
- FDA UDI 2cb8f45b-8053-49a9-ad77-db306d14d030 35 fields · synced Jun 8, 2026