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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
4-Lead ECG Modular Trunk Cable (AAMI) 8ft FDA UDI
Model / Reference
01-2177 FDA UDI
Description
4-Lead ECG Modular Trunk Cable (AAMI) 8ft FDA UDI

Identifiers

Primary DI / UDI-DI
05060472441195 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

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 6f7b7266-f15e-4cf4-887e-80c2170d38c6 33 fields · synced May 30, 2026