Fetal Measurements

Basic Information

• Brand Name: Fetal Measurements
• Primary DI: 20884838007431
• Version / Model: FETAL SPIRAL ELECTRODE
• Catalog Number: 989803137631
• Company Name: Philips Medical Systems Hsg
• Labeler DUNS: 790605856
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-11-08
• Public Version: 8
• Public Version Date: 2022-11-21
• Public Version Status: Update
• Public Device Record Key: 4fe0a115-4e9d-4e1f-982a-cc59e186de27

Device Description

Fetal Spiral Electrode, Single Spiral, 25 each/Box

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
Primary	20884838007431	GS1
Unit of Use	00884838007437	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 41 – 86 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 0 – 100 Percent (%) Relative Humidity