TrueLabor Maternal Unit

Basic Information

• Brand Name: TrueLabor Maternal Unit
• Primary DI: 07290016406016
• Version / Model: FG0001(X)
• Catalog Number: FG0001(X)
• Company Name: O.B - TOOLS LTD
• Labeler DUNS: 534149604
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: daedbf55-d371-41df-996f-f7212d78fe6a

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	884.2740	2
OSP	Uterine Electromyographic Monitor	Obstetrics/Gynecology	884.2720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38479	Cardiotocography telemetric monitoring system	An assembly of devices intended to be used to continuously measure and wirelessly transmit foetal heart rate and uterine contraction signals from a patient to a cardiotocograph/monitor. It typically consists of wireless patient worn transducers/electrodes (e.g., leads and electrodes or Doppler ultrasound transducer plus pressure transducer) with appropriate transmitting capability and a receiver unit; the cardiotocograph/monitor is not included. The system is typically used for ambulatory patients who require continuous monitoring before delivery.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016406016	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	90	Millimeter
Height	125	Millimeter
Depth	29	Millimeter
Weight	240	Gram

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep in cool dry place