FDA.reportPublic FDA data

TrueLabor Maternal Unit

Primary DI
07290016406016
Brand
TrueLabor Maternal Unit
Company
O.B - TOOLS LTD
Model
FG0001(X)
Catalog number
FG0001(X)
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.
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGMSystem, Monitoring, Perinatal
OSPUterine Electromyographic Monitor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGMSystem, Monitoring, PerinatalObstetrics/Gynecology2
OSPUterine Electromyographic MonitorObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016406016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016406016072900164060167290016406016

GMDN Terms#

Term, Definition table
TermDefinition
Cardiotocography telemetric monitoring systemAn 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth29Millimeter
Height125Millimeter
Weight240Gram
Width90Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep in cool dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+97246040162info@ob-tools.com

Regulatory Flags#

DUNS number
534149604
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016406030EmbraceTM Electrodes Array (L)FG0003(X)FG0003(X)2017-02-12
07290016406023TrueLabor Monitor AdapterFG0002(X)FG0002(X)2016-09-21

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Primary DI, Brand, Company table
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