FDA.reportPublic FDA data

VIVE

Primary DI
00818323028447
Brand
VIVE
Company
VIVE HEALTH LLC
Model
SUP2003
Device description
Wrist Ice Wrap
Published
2019-07-23
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
CodeName
ILHSplint, Hand, And Components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILHSplint, Hand, And ComponentsPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818323028444PackageGS120In Commercial Distribution
00818323028447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081832302844410818323028444
00818323028447008183230284478183230284470818323028447

GMDN Terms#

Term, Definition table
TermDefinition
Ice bagA flexible container (a bag) designed to be filled with ice to provide dry cold therapy to a limited external surface area of the body. It is typically made of plastic or rubber materials with a detachable cap that can be threaded or fixed to the bag once it is filled with ice. It may include a holder or attachments to facilitate fixing or holding the device in place against the body surface of the patient. It can be used to alleviate pain and/or promote healing in minor injuries of the body, e.g., after minor surgery, bruises, tissue swelling, or for application around the neck or limbs. This is a reusable device.

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810226440104ViveLVA3167BLK2026-06-04
00810226440111ViveLVA3167BLKPAK22026-06-04
00810178889969ViveLVA3166WHT2026-06-03
00810178889976ViveLVA3164BBB2026-06-03
00810178889983ViveLVA3164BBP2026-06-03
00810178889990ViveLVA3164BGN2026-06-03
00810226440005ViveLVA3165BB2026-06-03
00810226440012ViveLVA3165BP2026-06-03
00810226440029ViveLVA3165GN2026-06-03
00810226440036ViveSUP3008BLU2026-06-03
00810226440043ViveSUP3008PNK2026-06-03
00810178889624Vive BreatheLVA31612026-06-01
00810178889921ViveCareRHB3079S100CT2026-05-29
00810178889938ViveCareRHB3079M100CT2026-05-29
00810178889945ViveCareRHB3079L50CT2026-05-29
00810178889723ViveSUP3158BLKXS2026-05-27
00810178889730ViveSUP3158BLKS2026-05-27
00810178889747ViveSUP3158BLKM2026-05-27
00810178889754ViveSUP3158BLKL2026-05-27
00810178889761ViveSUP3158BLKXL2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810226440036ViveVIVE HEALTH LLCILH2026-06-03
00810226440043ViveVIVE HEALTH LLCILH2026-06-03
00057475274139BIOS LivingThermor LtdILH2023-09-18
00057475210175BIOS LivingThermor LtdILH2023-09-15
00057475210182BIOS LivingThermor LtdILH2023-09-15
10680651299854HalyardO&M HALYARD, INC.ILH2023-07-31
20680651299004HalyardO&M HALYARD, INC.ILH2023-06-07
00057475210441BIOS LivingThermor LtdILH2023-03-31
00057475210472BIOS LivingThermor LtdILH2023-03-31
00609271100053DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100152DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100251DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100350DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100459DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101050DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101159DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101258DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101357DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101456DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427006BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427013BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427020BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427037BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427044BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427051BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427068BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427075BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427082BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427099BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271610484SPLINT, WRIST, LACE-UP, RIGHT, X-SMALLDARCO INTERNATIONAL, INC.ILH2023-02-08