AccessGUDID - DEVICE: NATUS NEUROLOGY (00382830028257)

GUDID

Device Identifier (DI) Information

Brand Name: NATUS NEUROLOGY
Version or Model: X1F011
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NATUS NEUROLOGY INCORPORATED

Primary DI Number: 00382830028257
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 874257488 *Terms of Use

Device Description: IR PROBE 5 MHZ, CE MARK

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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). This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

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). This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
KNG	Monitor, Ultrasonic, Fetal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K944196	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5fc78e80-5d57-4564-95fa-6219bce1329e
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 15, 2016