NATUS NEUROLOGY

Basic Information

• Brand Name: NATUS NEUROLOGY
• Primary DI: 00382830028264
• Version / Model: X1F010
• Company Name: NATUS NEUROLOGY INCORPORATED
• Labeler DUNS: 874257488
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 4
• Public Version Date: 2023-11-03
• Public Version Status: Update
• Public Device Record Key: 17d97377-d3ec-42c8-ab7c-b0b2691ec4b4

Device Description

IR PROBE 3 MHZ,CE MARK

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNG	Monitor, Ultrasonic, Fetal	Obstetrics/Gynecology	884.2660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36970	Noninvasive vascular ultrasound system probe	A hand-operated component of a noninvasive vascular ultrasound system intended to be placed on the surface of a patient's body to measure the flow of blood in the underlying vasculature using ultrasonic/Doppler/transit time technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow graphically, typically with sound. The device is available in various frequency capacities (e.g., 4, 5, or 8 MHz). It may also be used to detect the foetal heartbeat. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00382830028264	GS1

Premarket Submissions

Submission Number	Supplement Number
K944196	000