Home GUDID 10814247021196 FSE
Primary DI 10814247021196
Brand FSE
Company CLINICAL INNOVATIONS, LLC
Model FSE-025S
Device description Fetal Spiral Electrode
Published 2023-09-27
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name HGP Electrode, Circular (Spiral), Scalp And Applicator
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HGP Electrode, Circular (Spiral), Scalp And Applicator Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10814247021196 Package GS1 25 In Commercial Distribution 20814247021193 Package GS1 4 In Commercial Distribution 00814247021199 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10814247021196 10814247021196 20814247021193 20814247021193 00814247021199 00814247021199 814247021199 0814247021199
GMDN Terms# Term, Definition table Term Definition Foetal scalp electrode, spiral A sterile electrical conductor designed to transmit electric signals from the foetal scalp to an intrapartum monitor. The device is a spiralled (either single- or double-helix) metallic electrode with a sharp tip that is directly inserted into the foetal scalp with a screwing action; and an adaptor cable that may include a transducer. The electrode penetrates into the scalp up to 2.5 mm (0.1 inch); it is usually inserted with a dedicated applicator that may be included. The electrode is typically used to monitor a foetal physiologic signal (e.g., heart rate) during labour (intrapartum) after rupture of the amniotic sac. This is a single-use device.
Regulatory Flags# DUNS number 809524291 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07340154900027 Goldtrace Fetal Spiral Electrode (FSE) Neoventa Medical AB HGP 2026-03-06 07340154900010 Goldtrace Fetal Spiral Electrode (FSE) Neoventa Medical AB HGP 2026-03-06 10889483588406 Vital Signs™ AirLife Finland Oy HGP 2025-03-31 20889483588403 Vital Signs™ AirLife Finland Oy HGP 2025-03-31 05055270977113 Rocket ROCKET MEDICAL PLC HGP 2023-10-24 05055270977144 Rocket ROCKET MEDICAL PLC HGP 2023-10-24 05055270977137 Rocket ROCKET MEDICAL PLC HGP 2023-10-24 05055270977168 Rocket ROCKET MEDICAL PLC HGP 2023-10-24 00814247021199 FSE CLINICAL INNOVATIONS, LLC HGP 2023-09-27 00814247021205 FSE Cables CLINICAL INNOVATIONS, LLC HGP 2023-09-27 10192253040500 Kendall Cardinal Health 200, LLC HGP 2022-05-27 10192253021158 Kendall Cardinal Health 200, LLC HGP 2021-02-23 50192253021156 Kendall Cardinal Health 200, LLC HGP 2021-02-23 10190752142176 Vital Signs™ AirLife Finland Oy HGP 2020-12-15 50190752142174 Vital Signs™ Vyaire Medical Oy HGP 2020-12-15 10192253020977 Kendall Cardinal Health 200, LLC HGP 2020-10-30 50192253020975 Kendall Cardinal Health, Inc. HGP 2020-10-30 B510FM30001 ADVANCED FETAL MONITOR ADVANCED INSTRUMENTATIONS, INC. HGP 2020-04-16 00884838007475 NA Philips Medical Systems Hsg HGP 2017-07-24 00884838007468 NA Philips Medical Systems Hsg HGP 2017-03-14 00884838007451 Fetal Measurements Philips Medical Systems Hsg HGP 2017-01-16 20884838007431 Fetal Measurements Philips Medical Systems Hsg HGP 2016-11-08 10885403252204 N/A Carefusion Finland 320 Oy HGP 2016-10-17 20885403252201 N/A Carefusion Finland 320 Oy HGP 2016-10-17 10884521081123 Kendall Cardinal Health, Inc. HGP 2016-09-24 10884527004911 Kendall Cardinal Health, Inc. HGP 2016-09-24 20884527002822 Kendall Cardinal Health, Inc. HGP 2016-09-24 20884521081120 Kendall Cardinal Health, Inc. HGP 2016-09-24 20884527004918 Kendall Cardinal Health, Inc. HGP 2016-09-24 20884527002815 Kendall Cardinal Health, Inc. HGP 2016-09-24