N/A

Basic Information

• Brand Name: N/A
• Primary DI: 10885403252204
• Version / Model: 2464AAO
• Catalog Number: 2464AAO
• Company Name: Carefusion Finland 320 Oy
• Labeler DUNS: 367919120
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-17
• Public Version: 4
• Public Version Date: 2020-10-26
• Public Version Status: Update
• Public Device Record Key: afec97c2-5b04-4db7-bb03-08250abb14c3

Device Description

Leg Attachment Pad for Corometrics™ Fetal Scalp Electrode Cable

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HGP	ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR	Obstetrics/Gynecology	884.2675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35038	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20885403252201	GS1	Box	50	In Commercial Distribution
Primary	10885403252204	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]