FDA.reportPublic FDA data

VIVE

Primary DI
00818323025903
Brand
VIVE
Company
VIVE HEALTH LLC
Model
SUP1050
Device description
Universal Arm Sling
Published
2019-01-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10818323025900PackageGS140In Commercial Distribution
00818323025903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081832302590010818323025900
00818323025903008183230259038183230259030818323025903

GMDN Terms#

Term, Definition table
TermDefinition
Shoulder immobilizer/orthosis, reusableA prefabricated (non-customized) non-rigid wearable device designed to support, align, and/or temporarily immobilize the shoulder joint to support the healing of an injury or surgical wound. It will typically consist of straps, buckles, fasteners, or be in the form of a sling. 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
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
00810178883127ViveSUP3108S2026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178880249ViveVIVE HEALTH LLCILE2025-07-08
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
10818323025900VIVEVIVE HEALTH LLCILE2019-01-19