Vital Signs™

Primary DI: 50190752142174
Brand: Vital Signs™
Company: Vyaire Medical Oy
Model: 7000AAO
Catalog number: 7000AAO
Device description: Fetal Spiral Electrode For Corometrics
Published: 2020-12-15
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

Related Records

Contact Domains

vyaire.com

Product Codes

Code	Name
HGP	Electrode, Circular (Spiral), Scalp And Applicator

Product Code Classifications

Code	Device	Specialty	Class
HGP	Electrode, Circular (Spiral), Scalp And Applicator	Obstetrics/Gynecology	2

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
50190752142174	Package	GS1	50	In Commercial Distribution
10190752142176	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized
50190752142174	50190752142174
10190752142176	10190752142176

GMDN Terms

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.

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.

Sterilization Methods

Method

Contacts

Phone	Email
+1-833-327-3284	customersupport@vyaire.com

Regulatory Flags

DUNS number: 368457563
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: false
Expiration date on label: true
Donation ID number: false
Contains natural rubber latex: false
No natural rubber latex: false
Sterilization required before use: false

Other Devices From This Company

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10190752106536	Multi-Link™	411200-001	411200-001	2018-11-23
10190752106543	Multi-Link™	411200-002	411200-002	2018-11-23
10190752106574	Multi-Link™	411200-005	411200-005	2018-11-23
10190752106581	Multi-Link™	411202-001	411202-001	2018-11-23
10190752106598	Multi-Link™	411202-002	411202-002	2018-11-23
10190752106628	Multi-Link™	411202-005	411202-005	2018-11-23
10190752106642	Multi-Link™	411203-001	411203-001	2018-11-23
10190752106659	Multi-Link™	411203-002	411203-002	2018-11-23
10190752106680	Multi-Link™	412681-001	412681-001	2018-11-23
10190752106697	Multi-Link™	412681-002	412681-002	2018-11-23
10190752106741	Multi-Link™	412682-001	412682-001	2018-11-23
10190752106758	Multi-Link™	412682-002	412682-002	2018-11-23
10190752106789	Multi-Link™	414556-001	414556-001	2018-11-23
10190752106796	Multi-Link™	414556-002	414556-002	2018-11-23
10190752106826	Multi-Link™	414556-005	414556-005	2018-11-23
10190752106840	Multi-Link™	416467-001	416467-001	2018-11-23
10190752106864	Multi-Link™	416467-003	416467-003	2018-11-23
10190752106888	Multi-Link™	416468-001	416468-001	2018-11-23
10190752106901	Multi-Link™	416468-003	416468-003	2018-11-23
10190752106925	Multi-Link™	421930-001	421930-001	2018-11-23

Other Devices Sharing Product Codes

Primary DI	Brand	Company	Product code	Published
07340154900010	Goldtrace Fetal Spiral Electrode (FSE)	Neoventa Medical AB	HGP	2026-03-06
20889483588403	Vital Signs™	AirLife Finland Oy	HGP	2025-03-31
05055270977137	Rocket	ROCKET MEDICAL PLC	HGP	2023-10-24
05055270977168	Rocket	ROCKET MEDICAL PLC	HGP	2023-10-24
10814247021196	FSE	CLINICAL INNOVATIONS, LLC	HGP	2023-09-27
00814247021205	FSE Cables	CLINICAL INNOVATIONS, LLC	HGP	2023-09-27
50192253021156	Kendall	Cardinal Health 200, LLC	HGP	2021-02-23
50192253020975	Kendall	Cardinal Health, Inc.	HGP	2020-10-30
00884838007475	NA	Philips Medical Systems	HGP	2017-07-24
00884838007468	NA	Philips Medical Systems	HGP	2017-03-14
00884838007451	NA	Philips Medical Systems	HGP	2017-01-16
20884838007431	NA	Philips Medical Systems	HGP	2016-11-08
20885403252201	N/A	Carefusion Finland 320 Oy	HGP	2016-10-17
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
10884527002825	Kendall	Cardinal Health, Inc.	HGP	2016-09-24
50885403248960	Vital Signs	Carefusion Finland 320 Oy	HGP	2016-09-14
00814247020505	Spiral Fetal Scalp Electrode	CLINICAL INNOVATIONS, LLC	HGP	2016-09-01
00814247020512	FSE Cables	CLINICAL INNOVATIONS, LLC	HGP	2016-09-01
00814247020529	FSE Cables	CLINICAL INNOVATIONS, LLC	HGP	2016-09-01
00814247020536	FSE Cables	CLINICAL INNOVATIONS, LLC	HGP	2016-09-01
00814247020543	FSE Cables	CLINICAL INNOVATIONS, LLC	HGP	2016-09-01
00814247020550	FSE Cables	CLINICAL INNOVATIONS, LLC	HGP	2016-09-01
00814247020567	FSE Cables	CLINICAL INNOVATIONS, LLC	HGP	2016-09-01
00814247020574	FSE Cables	CLINICAL INNOVATIONS, LLC	HGP	2016-09-01
00814247020581	FSE Cables	CLINICAL INNOVATIONS, LLC	HGP	2016-09-01
00814247020598	FSE Cables	CLINICAL INNOVATIONS, LLC	HGP	2016-09-01
20814247020745	Goldtrace One	CLINICAL INNOVATIONS, LLC	HGP	2016-09-01