VYGON

Basic Information

• Brand Name: VYGON
• Primary DI: 03660812019101
• Version / Model: 5534.91
• Catalog Number: 5534.91
• Company Name: VYGON
• Labeler DUNS: 392994778
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-28
• Public Version: 3
• Public Version Date: 2018-10-22
• Public Version Status: Update
• Public Device Record Key: d6a6fcbb-1dfd-4f49-8568-8b72e95f4f10

Device Description

Mucus extractor

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: Yes
• 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
BSY	CATHETERS, SUCTION, TRACHEOBRONCHIAL	Anesthesiology	868.6810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47776	General specimen container IVD, no additive, sterile	A sterile covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of any type of diagnostic specimen (e.g., urine, faeces, sputum, mucous, tissue) for analysis and/or other investigation. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	33660812019102	GS1	Box	25	In Commercial Distribution
Primary	03660812019101	GS1
Package	53660812019106	GS1	Case	6	In Commercial Distribution

Storage Conditions

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