Artic Flex

Basic Information

• Brand Name: Artic Flex
• Primary DI: 00818323024463
• Version / Model: RHB1063BLU
• Company Name: VIVE HEALTH LLC
• Labeler DUNS: 047025993
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-24
• Public Version: 1
• Public Version Date: 2019-04-01
• Public Version Status: New
• Public Device Record Key: cce55486-a209-4a1a-982c-32ffa5181585

Device Description

Eye Gel Mask

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	890.5700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35063	Eye mask	A mechanical shield intended to be fitted over the eyes to prevent the intrusion of light, typically to facilitate rest or sleep in illuminated environments and/or at home. It typically consists of an external covering made of an opaque plastic, or other appropriate material, that does not allow the passage of light and that is lined with a padded inner liner (e.g., foam, gauze); it is held in place with a strap(s). It is intended for single-patient use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10818323024460	GS1	Case	20	In Commercial Distribution
Primary	00818323024463	GS1