This standard is issued under the fixed designation E 1427; the number immediately following the designation indicates the year of.

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.

Code: HGPDevice Name: Electrode, Circular (Spiral), Scalp And ApplicatorDevice Class: 2Physical State: N/ADefinition: N/ASubmission Type ID: 1Review Panel: OBReview Code: N/ATechnical Method: NGmp Exempt Flag: N/ALife Sustain Support Flag: NUnclassified Reason: N/AImplant Flag: NTarget Area: N/ARegulation Number: 884.2675Third Party Flag: YMedical Specialty: OB

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Device Id: 50885403248960Device Type: PackageDeviceId Issuing Agency: GS1Contains DI Number: 10885403248962Package Quantity: 50Package Discontinue Date: 3/31/2022 12:00:00 AMPackage Status: Not in Commercial DistributionPackage Type: CaseDevice Id: 10885403248962Device Type: PrimaryDeviceId Issuing Agency: GS1Contains DI Number: N/APackage Quantity: N/APackage Discontinue Date: N/APackage Status: N/APackage Type: N/A

... arm 241. an end 219 of a chain 241b for moving the arm 241 is engaged within the slide unit 201 by way of a compression coil spring 219a which serves as ...