AccessGUDID - DEVICE: NeoBar® (00812594011849)

GUDID

Device Identifier (DI) Information

Brand Name: NeoBar®
Version or Model: Assorted
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N719N
Company Name: Neotech Products LLC

Primary DI Number: 00812594011849
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 198013435 *Terms of Use

Device Description: The NeoBar is intended to secure an endotracheal tube. It is intended for use on pediatric (neonates, infants and children) patients.

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":	Yes
For Single-Use:	Yes
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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35815	Endotracheal tube holder	A device designed to hold and stabilize an endotracheal (ET) tube when it has been intubated into a patient; it may also include a teeth protector to prevent damage to the teeth or tube during intubation. It typically consists of straps, pinch rings, cloth ties, or Velcro bands and provides the advantage of easy readjustment of the tube without retaping or the use of safety pins. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBH	Device, Fixation, Tracheal Tube

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 86a49b60-8d5d-4dc8-b093-1213e14d3972
Public Version Date: September 20, 2023
Public Version Number: 4
DI Record Publish Date: June 02, 2021