FDA.reportPublic FDA data

Vive

Primary DI
00810113570235
Brand
Vive
Company
VIVE HEALTH LLC
Model
SUP3010S
Device description
Broken Rib Brace (Small)
Published
2023-02-27
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
MRIOrthosis, Truncal/Orthosis, Limb

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRIOrthosis, Truncal/Orthosis, LimbPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810113570232PackageGS1100In Commercial Distribution
00810113570235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081011357023210810113570232
00810113570235008101135702358101135702350810113570235

GMDN Terms#

Term, Definition table
TermDefinition
Rib/sternum binder, reusableA reinforced wrap or garment designed to support the sternum (the breastbone), ribs, and chest (e.g., to support a sternum/rib fracture or support the chest post cardiothoracic surgery). It may be referred to as a chest binder or sternum splint. 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
00850040983005WoodyKnowsM&M Pure Air Systems LLCMRI2026-05-19
00850040983012WoodyKnowsM&M Pure Air Systems LLCMRI2026-05-19
00850040983029WoodyKnowsM&M Pure Air Systems LLCMRI2026-05-19
00645517890821TrulifeTRULIFE LIMITEDMRI2025-09-11
00645517892757TrulifeTRULIFE LIMITEDMRI2025-09-11
00645517892764TrulifeTRULIFE LIMITEDMRI2025-09-11
00645517898766TrulifeTRULIFE LIMITEDMRI2025-09-11
00645517899077TrulifeTRULIFE LIMITEDMRI2025-09-11
00645517899121TrulifeTRULIFE LIMITEDMRI2025-09-11
00645517897776TrulifeTRULIFE LIMITEDMRI2025-08-25
04719879646108ComfyHealthComfy Health Group Co., Ltd.MRI2025-07-10
04719879646115ComfyHealthComfy Health Group Co., Ltd.MRI2025-07-10
04719879646122ComfyHealthComfy Health Group Co., Ltd.MRI2025-07-10
04719879646139ComfyHealthComfy Health Group Co., Ltd.MRI2025-07-10
04719879646146ComfyHealth Comfy Health Group Co., Ltd.MRI2025-07-10
04719879646153ComfyHealthComfy Health Group Co., Ltd.MRI2025-07-10
04719879646160ComfyHealthComfy Health Group Co., Ltd.MRI2025-07-10
04719879646177ComfyHealthComfy Health Group Co., Ltd.MRI2025-07-10
04719879646566ComfyHealthComfy Health Group Co., Ltd.MRI2025-07-10
04719879646580ComfyHealthComfy Health Group Co., Ltd.MRI2025-07-10
00819567011639ComfytopiaComfytopia, Inc.MRI2025-07-09
00819567012452ComfytopiaComfytopia, Inc.MRI2025-07-09
00819567012469ComfytopiaComfytopia, Inc.MRI2025-07-09
00819567017839ComfytopiaComfytopia, Inc.MRI2025-07-09
00819567017846ComfytopiaComfytopia, Inc.MRI2025-07-09
00854194003107ComfytopiaComfytopia, Inc.MRI2025-07-09
00854194003114ComfytopiaComfytopia, Inc.MRI2025-07-09
00854194003480ComfytopiaComfytopia, Inc.MRI2025-07-09
00810178881567CoreTechVIVE HEALTH LLCMRI2025-05-19
10810178881564CoreTechVIVE HEALTH LLCMRI2025-05-19