AccessGUDID - DEVICE: TrueLabor Maternal Unit (07290016406016)

GUDID

Device Identifier (DI) Information

Brand Name: TrueLabor Maternal Unit
Version or Model: FG0001(X)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FG0001(X)
Company Name: O.B - TOOLS LTD

Primary DI Number: 07290016406016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 534149604 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HGM	System, Monitoring, Perinatal
OSP	Uterine Electromyographic Monitor

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep in cool dry place

Clinically Relevant Size

[?]

Size Type Text
Width: 90 Millimeter
Height: 125 Millimeter
Depth: 29 Millimeter
Weight: 240 Gram

Device Record Status

Public Device Record Key: daedbf55-d371-41df-996f-f7212d78fe6a
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 21, 2016