DEVICE: TrueLabor Monitor Adapter (07290016406023)
Device Identifier (DI) Information
TrueLabor Monitor Adapter
FG0002(X)
In Commercial Distribution
FG0002(X)
O.B - TOOLS LTD
FG0002(X)
In Commercial Distribution
FG0002(X)
O.B - TOOLS LTD
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep in cool dry place |
Clinically Relevant Size
[?]Size Type Text |
---|
Depth: 30 Millimeter |
Width: 200 Millimeter |
Height: 120 Millimeter |
Weight: 400 Gram |
Device Record Status
cd4dd79e-64fc-46e5-b1b8-7c6bbfe86392
March 29, 2018
2
September 21, 2016
March 29, 2018
2
September 21, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+97246040162
info@ob-tools.com
info@ob-tools.com