AccessGUDID - DEVICE: VYGON (03660812110730)

GUDID

Device Identifier (DI) Information

Brand Name: VYGON
Version or Model: 5576.02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00557602
Company Name: VYGON

Primary DI Number: 03660812110730
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 392994778 *Terms of Use

Device Description: bO2ugie Boussignac Oro-tracheal tubing for difficult intubations with oxygen injection - Ø4mm - 5.5mm

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?
42084	Endotracheal tube guide, single-use	A device used to provide guidance when it is necessary to exchange an endotracheal (ET) tube which has been intubated into a patient. The guide is inserted into the existing tube which is then retracted over the guide. The new ET tube is inserted over the guide to facilitate its correct passage, and the guide is removed once the new tube is satisfactorily in place. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSR	STYLET, 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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 14822a29-0a1a-4430-a4d6-03fbf165c04c
Public Version Date: June 17, 2021
Public Version Number: 1
DI Record Publish Date: June 09, 2021