VYGON

Basic Information

• Brand Name: VYGON
• Primary DI: 03660812088749
• Version / Model: 37.09.15
• Catalog Number: 00370915
• 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: 7b3e6ddf-66ba-4fd1-a174-3a3de8877b4f

Device Description

Neohelp Medium - 38x44cm

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
KME	BEDDING, DISPOSABLE, MEDICAL	General Hospital	880.6060	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62340	Hypothermia-prevention whole-body suit	A full-body overall intended to be worn by a patient in a clinical setting to minimize loss of body heat when the patient experiences low body temperature and/or is under at-risk conditions for low body temperature (e.g., long surgical procedures). It is typically a multilayer or multi-laminate suit made of synthetic materials including a layer with heat-insulating properties to facilitate retention of body heat. This is a reusable device after appropriate cleaning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	53660812088744	GS1	Case	4	In Commercial Distribution
Package	33660812088740	GS1	Box	10	In Commercial Distribution
Primary	03660812088749	GS1

Storage Conditions

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