VIVE

Basic Information

• Brand Name: VIVE
• Primary DI: 00810041981806
• Version / Model: SUP2043
• Company Name: VIVE HEALTH LLC
• Labeler DUNS: 047025993
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-07
• Public Version: 1
• Public Version Date: 2020-04-15
• Public Version Status: New
• Public Device Record Key: 752c5c8b-6a9f-41dc-87b2-73a3131397e9

Device Description

4350 Air Cushion Ankle Brace

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
ITW	Joint, Ankle, External Brace	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30999	Ankle joint orthosis	An externally applied orthopaedic device used as a component of a lower limb orthosis to allow or control motion of the ankle joint. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10810041981803	GS1	Case	1	In Commercial Distribution
Primary	00810041981806	GS1