FDA.reportPublic FDA data

Kendall

Primary DI
10192253040500
Brand
Kendall
Company
Cardinal Health 200, LLC
Model
31479549
Catalog number
31479549
Device description
Fetal Spiral Electrode Single Helix
Published
2022-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HGPElectrode, circular (spiral), scalp and applicator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGPElectrode, Circular (Spiral), Scalp And ApplicatorObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253040508PackageGS150In Commercial Distribution
10192253040500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225304050850192253040508
1019225304050010192253040500

GMDN Terms#

Term, Definition table
TermDefinition
Foetal scalp electrode, spiralA 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
961027315
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380213281CARDINAL HEALTHCAH4403CAH44032026-05-27
10192253047486Telfa766776672025-09-08
50885380140233CONVERTORS8337N8337N2018-08-20
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07340154900027Goldtrace Fetal Spiral Electrode (FSE)Neoventa Medical ABHGP2026-03-06
07340154900010Goldtrace Fetal Spiral Electrode (FSE)Neoventa Medical ABHGP2026-03-06
10889483588406Vital Signs™AirLife Finland OyHGP2025-03-31
20889483588403Vital Signs™AirLife Finland OyHGP2025-03-31
05055270977113RocketROCKET MEDICAL PLCHGP2023-10-24
05055270977144RocketROCKET MEDICAL PLCHGP2023-10-24
05055270977137RocketROCKET MEDICAL PLCHGP2023-10-24
05055270977168RocketROCKET MEDICAL PLCHGP2023-10-24
00814247021199FSECLINICAL INNOVATIONS, LLCHGP2023-09-27
10814247021196FSECLINICAL INNOVATIONS, LLCHGP2023-09-27
00814247021205FSE CablesCLINICAL INNOVATIONS, LLCHGP2023-09-27
10192253021158KendallCardinal Health 200, LLCHGP2021-02-23
50192253021156KendallCardinal Health 200, LLCHGP2021-02-23
10190752142176Vital Signs™AirLife Finland OyHGP2020-12-15
50190752142174Vital Signs™Vyaire Medical OyHGP2020-12-15
10192253020977KendallCardinal Health 200, LLCHGP2020-10-30
50192253020975KendallCardinal Health, Inc.HGP2020-10-30
B510FM30001ADVANCED FETAL MONITORADVANCED INSTRUMENTATIONS, INC.HGP2020-04-16
00884838007475NAPhilips Medical Systems HsgHGP2017-07-24
00884838007468NAPhilips Medical Systems HsgHGP2017-03-14
00884838007451Fetal MeasurementsPhilips Medical Systems HsgHGP2017-01-16
20884838007431Fetal MeasurementsPhilips Medical Systems HsgHGP2016-11-08
10885403252204N/ACarefusion Finland 320 OyHGP2016-10-17
20885403252201N/ACarefusion Finland 320 OyHGP2016-10-17
10884521081123KendallCardinal Health, Inc.HGP2016-09-24
10884527004911KendallCardinal Health, Inc.HGP2016-09-24
20884527002822KendallCardinal Health, Inc.HGP2016-09-24
20884521081120KendallCardinal Health, Inc.HGP2016-09-24
20884527004918KendallCardinal Health, Inc.HGP2016-09-24
20884527002815KendallCardinal Health, Inc.HGP2016-09-24