VYGON

Basic Information

• Brand Name: VYGON
• Primary DI: 03660812032841
• Version / Model: 5570.13
• Catalog Number: 5570.13
• Company Name: VYGON
• Labeler DUNS: 392994778
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-14
• Public Version: 4
• Public Version Date: 2020-04-20
• Public Version Status: Update
• Public Device Record Key: 00198bf7-66a1-4d88-83d8-db19829cf114

Device Description

Boussignac / Vygon CPAP

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: Yes
• PM Exempt: No
• 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
BYE	Attachment, breathing, positive end expiratory pressure	Anesthesiology	868.5965	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61654	In-line CPAP pressure generating chamber	A sterile portable device intended to be integrated between a medical gas supply and a face mask/mouthpiece (not included) to assist noninvasive ventilation (i.e., without an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous patient respiration in respiratory emergency situations and/or respiratory therapy settings. It is typically a small plastic unit intended to be used with a separate flowmeter and manometer to establish a gas pressure proportional to gas flow rate through turbulent gas flow in an internal chamber using accelerating micro-channels (a virtual valve); tubing may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	53660812032846	GS1		12	In Commercial Distribution
Package	33660812032842	GS1		5	In Commercial Distribution
Primary	03660812032841	GS1

Premarket Submissions

Submission Number	Supplement Number
K013884	000

Storage Conditions

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