VIVE

Basic Information

• Brand Name: VIVE
• Primary DI: 00810041980274
• Version / Model: LVA2037BLK
• Company Name: VIVE HEALTH LLC
• Labeler DUNS: 047025993
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-30
• Public Version: 1
• Public Version Date: 2023-07-10
• Public Version Status: New
• Public Device Record Key: 928d7e11-b2ba-4be1-ab4b-9265385940ba

Device Description

Rollator Bag (Black)

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
KNO	Accessories, Wheelchair	Physical Medicine	890.3910	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38495	Wheelchair article holder	A container (e.g., a wire basket, nylon tote bag, or plastic box) that provides a wheelchair occupant with a receptacle for items (e.g., personal/shopping items, work supplies). The device can be mounted at various locations on the wheelchair depending on the type of wheelchair and configuration of the device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10810041980271	GS1	Case	30	In Commercial Distribution
Primary	00810041980274	GS1