FDA.reportPublic FDA data

Vive

Primary DI
00818323021950
Brand
Vive
Company
VIVE HEALTH LLC
Model
SUP1077S
Device description
Bamboo Wrist (Black) Small
Published
2019-03-17
Public version status
Update
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
10818323021957PackageGS140In Commercial Distribution
00818323021950PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081832302195710818323021957
00818323021950008183230219508183230219500818323021950

GMDN Terms#

Term, Definition table
TermDefinition
Wrist binder, reusableA dedicated strip/roll of fabric or polymer material designed to be wrapped around the wrist to support the wrist joint. It does not include a rigid support (i.e., not a wrist immobilizer) and is not a tubular support bandage. 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
00810178889723ViveSUP3158BLKXS2026-05-27
00810178889730ViveSUP3158BLKS2026-05-27
00810178889747ViveSUP3158BLKM2026-05-27
00810178889754ViveSUP3158BLKL2026-05-27
00810178889761ViveSUP3158BLKXL2026-05-27
00810178889778ViveSUP3159BLKXS2026-05-27
00810178889785ViveSUP3159BLKS2026-05-27
00810178889792ViveSUP3159BLKM2026-05-27
00810178889808ViveSUP3159BLKL2026-05-27
00810178889815ViveSUP3159BLKXL2026-05-27
00810178889822ViveSUP3160BLKXS2026-05-27
00810178889839ViveSUP3160BLKS2026-05-27
00810178889846ViveSUP3160BLKM2026-05-27
00810178889853ViveSUP3160BLKL2026-05-27
00810178889860ViveSUP3160BLKXL2026-05-27
00810178889877ViveSUP3161BLKXS2026-05-27
00810178889884ViveSUP3161BLKS2026-05-27
00810178889891ViveSUP3161BLKM2026-05-27
00810178889907ViveSUP3161BLKL2026-05-27
00810178889914ViveSUP3161BLKXL2026-05-27

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
00818323023510Vive 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