VYGON

Basic Information

• Brand Name: VYGON
• Primary DI: 03660812109512
• Version / Model: 5576.03
• Catalog Number: 00557603
• Company Name: VYGON
• Labeler DUNS: 392994778
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-09
• Public Version: 1
• Public Version Date: 2021-06-17
• Public Version Status: New
• Public Device Record Key: 2102b2ac-6fde-40bf-a776-9ef6ed1a3d25

Device Description

bO2ugie Boussignac Oro-tracheal tubing for difficult intubations with oxygen injection - Ø2.5mm - 3.5mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BSR	STYLET, TRACHEAL TUBE	Anesthesiology	868.5790	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	33660812109513	GS1	Box	10	In Commercial Distribution
Primary	03660812109512	GS1
Package	53660812109517	GS1	Case	9	In Commercial Distribution

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius