AccessGUDID - DEVICE: Bio-logic (00382830052191)

GUDID

Device Identifier (DI) Information

Brand Name: Bio-logic
Version or Model: Foam Tips Pediatric
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 202121
Company Name: NATUS MEDICAL INCORPORATED

Primary DI Number: 00382830052191
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 962519208 *Terms of Use

Device Description: Foam Tips Insert Earphone, Pediatric

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62133	Audiometric ear tip	A non-sterile luminal device intended to be connected to the distal end of an audiometric sound delivery tube and inserted into the ear canal, to allow test sounds to be delivered to the ear in isolation from background noise. It is designed to create a seal inside the ear canal whilst allowing the sound tube to pass through the lumen. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EWO	Audiometer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K031352	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: ed47fbbb-9f2c-4cbc-9b38-ba5e04583583
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 30, 2016