FDA.reportPublic FDA data

Vive

Primary DI
00818323023510
Brand
Vive
Company
VIVE HEALTH LLC
Model
SUP1084BGE
Device description
Gel Thumb Support (Beige)
Published
2022-10-03
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
ILGStocking, Elastic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILGStocking, ElasticPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818323023517PackageGS1100In Commercial Distribution
00818323023510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081832302351710818323023517
00818323023510008183230235108183230235100818323023510

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure tubular garmentA device in the form of a tube intended to tightly fit over and apply compression/pressure (i.e., graduated or even-force) to a part of a limb, typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)], to control scarring, and/or to manage lymphoedema; it is neither a strip/roll binder, glove, sock/stocking, nor tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex); it does not include antimicrobial features. 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
00810041982483ViveLVA2057BLU2026-05-14
00818323022797ViveLVA1003PAK2 2026-05-11
00818323025279ViveLVA10032026-05-11
00810113576817ViveLVA3049BLKML6M72024-07-17
00810113576824ViveLVA3049BLKCM92024-07-17
00810113576831ViveLVA3049BLKBM62024-07-17
00810113579627ViveLVA3078WHTS2025-04-04
00810113579634ViveLVA3078WHTM2025-04-04
00810113579641ViveLVA3078WHTL2025-04-04
00810113579658ViveLVA3078WHTL2025-04-04
00810178883516ViveLVA3099BLK2025-07-17
00818323025002VIVELVA1099BLK2019-03-24
00818323025019VIVELVA1099GRY2019-03-24
00818323025026VIVELVA1099PUR2019-03-24
00810178883639ViveLVA3102BLK2025-08-07
00810178883301ViveLVA3098BLK2025-07-17
00810178883523ViveLVA3100BLK2025-07-17
00810178883530ViveLVA3100PUR2025-07-17
00810178881857ViveLVA3086BLUS2025-07-15
00810178881864ViveLVA3086BLUM2025-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199874682402Tournisec62K SOLUTIONS, LLCILG2025-12-15
00199874723976Tournisec62K SOLUTIONS, LLCILG2025-12-15
10199874723973Tournisec62K SOLUTIONS, LLCILG2025-12-15
10199874682409Tournisec62K SOLUTIONS, LLCILG2025-12-15
00818323021783ViveVIVE HEALTH LLCILG2024-09-06
00818323021790ViveVIVE HEALTH LLCILG2024-09-06
10818323021780ViveVIVE HEALTH LLCILG2024-09-06
10818323021797ViveVIVE HEALTH LLCILG2024-09-06
10850053289382SURGYCOSurgyco LLCILG2023-12-15
10850053289399SURGYCOSurgyco LLCILG2023-12-15
10850053289405SURGYCOSurgyco LLCILG2023-12-15
10850053289412SURGYCOSurgyco LLCILG2023-12-15
00850053289385SURGYCOSurgyco LLCILG2023-12-15
00850053289392SURGYCOSurgyco LLCILG2023-12-15
00850053289408SURGYCOSurgyco LLCILG2023-12-15
00850053289415SURGYCOSurgyco LLCILG2023-12-15
00810113570488ViveVIVE HEALTH LLCILG2023-08-23
10810113570485ViveVIVE HEALTH LLCILG2023-08-23
00810113570747ViveVIVE HEALTH LLCILG2022-11-28
10810113570744ViveVIVE HEALTH LLCILG2022-11-28
00818323023503Vive VIVE HEALTH LLCILG2022-10-03
10818323023500Vive VIVE HEALTH LLCILG2022-10-03
10818323023517Vive VIVE HEALTH LLCILG2022-10-03
10192253062434CONVERTORSCardinal Health 200, LLCILG2022-09-12
50192253062432CONVERTORSCardinal Health 200, LLCILG2022-09-12
00373317568212AUMSlv Pharmaceuticals LLCILG2022-03-08
00636257031308MEDIMEDI MANUFACTURING, INC.ILG2021-09-07
00636257031315MEDIMEDI MANUFACTURING, INC.ILG2021-09-07
00636257031322MEDIMEDI MANUFACTURING, INC.ILG2021-09-07
00636257031339MEDIMEDI MANUFACTURING, INC.ILG2021-09-07