AccessGUDID - DEVICE: Truer Bougie Coiled (00859290006465)

GUDID

Device Identifier (DI) Information

Brand Name: Truer Bougie Coiled
Version or Model: 90553
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TRUER MEDICAL, INC.

Primary DI Number: 00859290006465
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 003530786 *Terms of Use

Device Description: Truer Medical’s new Bougie is a latex-free, calibrated introducer designed to ensure accurate distance insertion.

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):	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?
41829	Endotracheal tube introducer, single-use	A device designed to help with the insertion of an endotracheal (ET) tube into the airways of a patient during intubation. It is a long, thin, rod-like device, typically angled at the distal end, designed to improve directional control of the endotracheal tube during routine or difficult oral intubations. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KCD	Bougie, Esophageal, Ent

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: 514078d3-982e-45eb-af5f-62b1a8bd3539
Public Version Date: October 02, 2023
Public Version Number: 1
DI Record Publish Date: September 22, 2023