FDA.reportPublic FDA data

Vive

Primary DI
00810226442818
Brand
Vive
Company
VIVE HEALTH LLC
Model
SUP3189BLK
Device description
Arm Sling Strap
Published
2026-10-01
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
00810226442818PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810226442818008102264428188102264428180810226442818

GMDN Terms#

Term, Definition table
TermDefinition
Arm immobilization sling, reusableA non-powered, non-rigid wearable device intended to support, align, and temporarily immobilize the arm (including the shoulder) to support the healing of an injury or surgical wound. It typically consists of a fabric or foam sling secured over the shoulder(s) with an adjustable strap and/or a strap around the abdomen and upper arm to secure the arm in place. It may be suspended from an overhead support to elevate the extremity to aid in controlling oedema, enhancing recovery typically following hand or forearm surgery. It is neither an elbow orthosis nor triangular bandage and does not include a hinge mechanism. This is a reusable device.

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
00810226442788ViveLVA3082WHTGRY2026-09-30
00810226440944ViveCareRHB3080TAN462026-09-29
00810226440951ViveCareRHB3080TAN482026-09-29
00810226440968ViveCareRHB3080TAN4102026-09-29
00810226442542ViveCareRHB3080TAN46PAK12026-09-29
00810226442559ViveCareRHB3080TAN48PAK12026-09-29
00810226442566ViveCareRHB3080TAN410PAK12026-09-29
00810226442696ViveMOB1169BLK2026-09-29
00810178885329Vive CareRHB3071B10OZ2026-09-28
00810178889235ViveLVA3156BLK2026-09-28
00810178889280CoreTechSUP3128BLKS2026-05-05
00810178889297CoreTechSUP3128BLKM2026-05-05
00810178889303CoreTechSUP3128BLKL2026-05-05
00810178889310CoreTechSUP3128BLKXL2026-05-05
00810178889327CoreTechSUP3128BLK2XL2026-05-05
00810226442306ViveDMD1087CUFF2026-08-25
00810226442245ViveCSH1116GRY2026-08-21
00810226442290ViveLVA3188BLK2026-08-21
00810178889648CoreTechSUP3156BLK2026-08-19
00810178889655ViveMOB1162BLK2026-08-19

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
00818323025903VIVEVIVE HEALTH LLCILE2019-01-19
10818323025900VIVEVIVE HEALTH LLCILE2019-01-19