Vive

Basic Information

• Brand Name: Vive
• Primary DI: 00818323025149
• Version / Model: SUP1030BGE
• Company Name: VIVE HEALTH LLC
• Labeler DUNS: 047025993
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-02
• Public Version: 1
• Public Version Date: 2022-09-12
• Public Version Status: New
• Public Device Record Key: a2327d35-92d3-4f51-83e1-a0e2d671cbef

Device Description

Calf Brace (Beige)

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
ITQ	Joint, Knee, External Brace	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65192	Calf/shin orthosis	A prefabricated (non-customized) externally applied and wearable appliance intended to be wrapped around the calf and shin to prevent or treat muscular conditions (e.g., shin splints). It is in the form of a wrap/sleeve with straps made of synthetic and textile materials intended to apply select pressure to specific muscles for support/relief. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10818323025146	GS1	Case	40	In Commercial Distribution
Primary	00818323025149	GS1