VIVE

Basic Information

• Brand Name: VIVE
• Primary DI: 00810041981431
• Version / Model: RHB2008
• Company Name: VIVE HEALTH LLC
• Labeler DUNS: 047025993
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-19
• Public Version: 2
• Public Version Date: 2022-11-09
• Public Version Status: Update
• Public Device Record Key: 89c4e513-9688-40da-a74e-5c7247072abc

Device Description

Warming Mitten

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	890.5700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11885	Utility glove	A hand-worn device intended to be used by healthcare personnel to protect the hands from contamination and/or injury during paraclinical/non-clinical activities (e.g., handling waste, instrument reprocessing). It may be available in a variety of forms or with specific attributes (e.g., rubber, reinforced, heat resistant, with extended sleeve), however is not intended to protect from extreme cold/cryogenic temperatures (i.e., not a cryogenic safety glove). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10810041981438	GS1	Case	1	In Commercial Distribution
Primary	00810041981431	GS1