FDA.reportPublic FDA data

TrueLabor Monitor Adapter

Primary DI
07290016406023
Brand
TrueLabor Monitor Adapter
Company
O.B - TOOLS LTD
Model
FG0002(X)
Catalog number
FG0002(X)
Device description
The TrueLabor's Monitor Adapter for the hospital maternal/fetal monitoring system. The corresponding Maternal Unit transmits the uterine activity/fetal heart rate information via Bluetooth to the MONITOR ADAPTER which transfers it to the hospital monitor or directly to the hospital IT system.
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
07290016406023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016406023072900164060237290016406023

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
Depth30Millimeter
Height120Millimeter
Weight400Gram
Width200Millimeter

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
07290016406016TrueLabor Maternal UnitFG0001(X)FG0001(X)2016-09-21

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