TrueLabor Maternal Unit

FDA UDI

Class II (US FDA UDI)

by Ob Tools, Ltd.

Identity

Trade Name: TrueLabor Maternal Unit FDA UDI
Generic Name: Cardiotocography telemetric monitoring system FDA UDI
Device Name: TrueLabor's Maternal Unit is connected via a proprietary connector to the Embrace electrode array. The MU acquires EMG signals and provides Fetal Heart Rate and Uterine Activity are transmitted via Bluetooth. The unit contains a Li-Ion rechargeable battery. FDA UDI
Model / Reference: FG0001(X) FDA UDI
Description: TrueLabor's Maternal Unit is connected via a proprietary connector to the Embrace electrode array. The MU acquires EMG signals and provides Fetal Heart Rate and Uterine Activity are transmitted via Bluetooth. The unit contains a Li-Ion rechargeable battery. FDA UDI

Identifiers

Catalog Number: FG0001(X) FDA UDI
Primary DI / UDI-DI: 07290016406016 FDA UDI
FDA Product Code: HGM FDA UDI
OSP FDA UDI
GMDN Term: Cardiotocography telemetric monitoring system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.2740 FDA UDI
884.2720 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

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

FDA UDI

Dimensions & Sizes

Size: Width — 90 Millimeter FDA UDI
Height — 125 Millimeter FDA UDI
Depth — 29 Millimeter FDA UDI
Weight — 240 Gram FDA UDI

Category: Cardiotocography telemetric monitoring system

TrueLabor Maternal Unit by Ob Tools, Ltd. — 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: Ob Tools, Ltd.

Sources (1)

FDA UDI daedbf55-d371-41df-996f-f7212d78fe6a 37 fields · synced May 30, 2026