Telemetry System. License + Software for up to 7 users

FDA UDI

Class II (US FDA UDI)

by Norav Medical Inc.

Identity

Trade Name: Telemetry System. License + Software for up to 7 users FDA UDI
Generic Name: Electrocardiography monitoring system receiver FDA UDI
Device Name: The NM-700 model, which is part of the PCECG1200 system, is designed to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value. FDA UDI
Model / Reference: NM-700BT FDA UDI
Description: The NM-700 model, which is part of the PCECG1200 system, is designed to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value. FDA UDI

Identifiers

Primary DI / UDI-DI: 07290110251192 FDA UDI
FDA Product Code: MWI FDA UDI
GMDN Term: Electrocardiography monitoring system receiver 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrocardiography monitoring system receiver

Telemetry System. License + Software for up to 7 users by Norav Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Norav Medical Inc.

Sources (1)

FDA UDI 04174b24-f8cb-4e48-baa2-f493404f1372 34 fields · synced May 31, 2026