Home GUDID 00810178883684 Vive
Primary DI 00810178883684
Brand Vive
Company VIVE HEALTH LLC
Model LVA3103GRY
Device description Fall Protection Helmet
Published 2025-08-07
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true Product Codes# Code, Name table Code Name NDA Helmet, Cranial, For Protective Use
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NDA Helmet, Cranial, For Protective Use Physical Medicine 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810178883684 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00810178883684 00810178883684 810178883684 0810178883684
GMDN Terms# Term, Definition table Term Definition Orthotic helmet A protective covering designed to be worn on the head (i.e., to encompass the brow, crown, back and sides of the head) to protect the cranium from non-penetrating external forces for the prevention/reduction of head injuries (e.g., mild traumatic brain injury). This is a reusable device.
Regulatory Flags# DUNS number 047025993 Device count 1 DM exempt true Premarket exempt true Other Devices From This Company#