FDA.reportPublic FDA data

Vive

Primary DI
00810178880249
Brand
Vive
Company
VIVE HEALTH LLC
Model
SUP3097BLKS
Device description
Abduction Sling (Advanced) Small
Published
2025-07-08
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
ILESling, Arm, Overhead Supported

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILESling, Arm, Overhead SupportedPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810178880246PackageGS14In Commercial Distribution
00810178880249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081017888024610810178880246
00810178880249008101788802498101788802490810178880249

GMDN Terms#

Term, Definition table
TermDefinition
Arm immobilizerA non-rigid device, usually made of a fabric, used to temporarily render the arm immovable, typically at the shoulder and elbow, to support healing of an injury or a surgical wound. 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
00810178887743ViveRHB3076M2026-08-07
00810041980229ViveSUP1064TAL2026-08-03
00810041980236ViveSUP1064BLU2026-08-03
00810041980243ViveSUP1064PNK2026-08-03
00810178885602ViveLVA2014PAK22026-08-03
00810226440722ViveMOB1163WHT2026-08-03
00810226441460ViveSUP1064GRY2026-08-03
00810226441477ViveSUP1064RED2026-08-03
00810226441484ViveSUP1064PUR2026-08-03
00810226441491ViveSUP1064PFL2026-08-03
00810226441507ViveSUP1064LPD2026-08-03
00810226441514ViveSUP1064USA2026-08-03
00810226441538ViveLVA3182BLK2026-08-03
00810226441545ViveLVA3180BGE2026-08-03
00810226441552ViveLVA3180BGEL2026-08-03
00818323021332ViveSUP1064BLK2026-08-03
00818323027358ViveLVA20142026-08-03
00818323026702ViveLVA1077PK482024-01-12
00818323026719ViveLVA1077PK722024-01-12
00810226441385ViveLVA3177BLK2026-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178880256ViveVIVE HEALTH LLCILE2025-07-08
00810178880263ViveVIVE HEALTH LLCILE2025-07-08
10810178880246ViveVIVE HEALTH LLCILE2025-07-08
10810178880253ViveVIVE HEALTH LLCILE2025-07-08
10810178880260ViveVIVE HEALTH LLCILE2025-07-08
06973712280388Elite BriteHengshui Tianjian Medical Supplies CO.,LTDILE2024-11-29
00810041980250ViveVIVE HEALTH LLCILE2024-09-06
10810041980257ViveVIVE HEALTH LLCILE2024-09-06
00810113575377ViveVIVE HEALTH LLCILE2024-06-10
00810113575384ViveVIVE HEALTH LLCILE2024-06-10
10810113575374ViveVIVE HEALTH LLCILE2024-06-10
10810113575381ViveVIVE HEALTH LLCILE2024-06-10
06973712280111ELITE BRITEHengshui Tianjian Medical Supplies CO.,LTDILE2024-06-03
06973712280296ELITE BRITEHengshui Tianjian Medical Supplies CO.,LTDILE2024-06-03
00810113573038ViveVIVE HEALTH LLCILE2023-10-18
10810113573035ViveVIVE HEALTH LLCILE2023-10-18
00818323020540VIVEVIVE HEALTH LLCILE2019-01-20
10818323020547VIVEVIVE HEALTH LLCILE2019-01-20
00818323025903VIVEVIVE HEALTH LLCILE2019-01-19
10818323025900VIVEVIVE HEALTH LLCILE2019-01-19