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Tempus Pro

FDA UDI

Class II (US FDA UDI)

by Remote Diagnostic Technologies Limited

Identity

Trade Name
Tempus Pro FDA UDI
Generic Name
Multiple vital physiological parameter monitoring system, clinical FDA UDI
Device Name
Tempus Pro Rainbow - with Capnometry & without BT Dock FDA UDI
Model / Reference
00-1004-R FDA UDI
Description
Tempus Pro Rainbow - with Capnometry & without BT Dock FDA UDI

Identifiers

Catalog Number
867420 FDA UDI
Primary DI / UDI-DI
05060472442901 FDA UDI
FDA Product Code
MHX FDA UDI
GMDN Term
Multiple vital physiological parameter monitoring system, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1025 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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Multiple vital physiological parameter monitoring system, clinical

Tempus Pro by Remote Diagnostic Technologies Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple vital physiological parameter monitoring system, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Remote Diagnostic Technologies Limited

Sources (1)

  • FDA UDI fb803ceb-c0b8-4d25-93a1-ab0a0e5d997c 34 fields · synced May 30, 2026