VYGON

Basic Information

• Brand Name: VYGON
• Primary DI: 03660812137263
• Version / Model: 5382.06
• Catalog Number: 5382.06
• Company Name: VYGON
• Labeler DUNS: 392994778
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-26
• Public Version: 1
• Public Version Date: 2021-09-03
• Public Version Status: New
• Public Device Record Key: 7503d29c-6e37-4cfa-a9a2-a3d8e35bafbb

Device Description

NeoSump Gastric Aspirator 06Fr Ø 1.2 x 2.0mm - L. 60cm

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: 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
KNT	Tubes, gastrointestinal (and accessories)	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65196	General specimen collection kit	A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium [e.g., preservation solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	53660812137268	GS1	Case	4	In Commercial Distribution
Package	33660812137264	GS1	Box	25	In Commercial Distribution
Primary	03660812137263	GS1

Storage Conditions

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