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Norav NR Series

FDA UDI

Class II (US FDA UDI)

by Norav Medical Inc.

Identity

Trade Name
Norav NR Series FDA UDI
Generic Name
Electrocardiographic signal amplifier FDA UDI
Device Name
Kit includes: Norav Telemetry ECG Recording Unit NR-314-T (UDI: 04260498565283) for 3 Channel ECG Telemetry with AHA type labelling; Input cable with 4 Patient leads AHA type and Snap connectors. FDA UDI
Model / Reference
NR-314-T Kit FDA UDI
Description
Kit includes: Norav Telemetry ECG Recording Unit NR-314-T (UDI: 04260498565283) for 3 Channel ECG Telemetry with AHA type labelling; Input cable with 4 Patient leads AHA type and Snap connectors. FDA UDI

Identifiers

Catalog Number
NR314T-K-00-U-S5-04 FDA UDI
Primary DI / UDI-DI
04260498566860 FDA UDI
FDA Product Code
MWI FDA UDI
GMDN Term
Electrocardiographic signal amplifier FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2300 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

Yes

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

Category: Electrocardiographic signal amplifier

Norav NR Series by Norav Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic signal amplifier.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Norav Medical Inc.

Sources (1)

  • FDA UDI 4f3597dd-5307-4636-8e51-8028f0d037b0 35 fields · synced Jun 7, 2026