VIVE

Basic Information

• Brand Name: VIVE
• Primary DI: 00818323026535
• Version / Model: INS1004S
• Company Name: VIVE HEALTH LLC
• Labeler DUNS: 047025993
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-09
• Public Version: 2
• Public Version Date: 2020-07-07
• Public Version Status: Update
• Public Device Record Key: 1e2bd196-5970-41da-8beb-bb48a1c8cb44

Device Description

Shock Gel Full Women's

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
KNP	Orthosis, Corrective Shoe	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59098	Orthotic insole, prefabricated, antimicrobial	A prefabricated orthopaedic shoe insert typically available for use by a layperson intended to provide supplemental support for the arch and/or heel of the foot, whilst inhibiting microbes such as viruses, bacteria and fungi. It is typically made of fabric and/or synthetic polymer materials (e.g., wool, viscose, silicone gel, foam) impregnated with an antimicrobial substance, which is designed to resist extreme load and may provide thermal insulation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10818323026532	GS1	Case	50	In Commercial Distribution
Primary	00818323026535	GS1