DEVICE: TrueLabor Monitor Adapter (07290016406023)

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Device Identifier (DI) Information

TrueLabor Monitor Adapter
FG0002(X)
FG0002(X)
O.B - TOOLS LTD
07290016406023
GS1
1
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
No
Yes
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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

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Size Type Text
Depth: 30 Millimeter
Width: 200 Millimeter
Height: 120 Millimeter
Weight: 400 Gram
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Device Status

In Commercial Distribution
September 21, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
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None
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Production Identifier(s) in UDI

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No
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No CLOSE

Customer Contact

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+97246040162
info@ob-tools.com
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