VIVE

Basic Information

• Brand Name: VIVE
• Primary DI: 00810041981035
• Version / Model: SUP2032
• Company Name: VIVE HEALTH LLC
• Labeler DUNS: 047025993
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-08
• Public Version: 3
• Public Version Date: 2022-10-31
• Public Version Status: Update
• Public Device Record Key: 61d4029f-9807-4492-9812-42d3d1ed5b7c
• Distribution End Date: 2022-10-31

Device Description

Tall Pneumatic Walking Boot

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
31045	Assistive shoes/boots	A device specially designed/adapted to be worn on the feet of a person with a disability for walking and activities (e.g., sport). It is typically constructed with features that facilitate easy donning, fastening, and removal (e.g., special shape, elastic laces).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10810041981032	GS1	Case	1	Not in Commercial Distribution	2022-10-31
Primary	00810041981035	GS1