SONCD FM800 ENCOR EXT TOCO TDR
SONICAID - ACC-OBS-009
Device Description
A pressure transducer intended to be placed on the abdomen of a labouring woman to convert uterine birthing contractions to electrical signals; the signals are typically displayed by a cardiotocograph (CTG). This is a reusable device.
Environmental Conditions
- 1060.00
- 680.00
- 75.00
- 10.00
- 35.00
- 10.00
- 1060.00
- 680.00
- 90.00
- 10.00
- 50.00
- -20.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: HGM
Device Name: System, Monitoring, Perinatal
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: OB
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 884.2740
Third Party Flag: Y
Medical Specialty: OB
Device IdentifiersDevice Id: 05051968029829
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A