FDA.reportPublic FDA data

Vive

Primary DI
10810113575374
Brand
Vive
Company
VIVE HEALTH LLC
Model
SUP3049BLK
Device description
Night Arm Sling (Universal)
Published
2024-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
10810113575374PackageGS120In Commercial Distribution
00810113575377PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081011357537410810113575374
00810113575377008101135753778101135753770810113575377

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
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