FDA.reportPublic FDA data

Vive

Primary DI
10810113576548
Brand
Vive
Company
VIVE HEALTH LLC
Model
SUP3062BLKUNI
Device description
Hernia Belt (Inguinal)
Published
2024-05-03
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
EXMTruss, Umbilical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXMTruss, UmbilicalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810113576548PackageGS120In Commercial Distribution
00810113576541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081011357654810810113576548
00810113576541008101135765418101135765410810113576541

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal hernia truss, reusableA device, typically in the form of a strap(s), designed to be worn over an abdominal hernia opening (weakness in the abdominal wall) to prevent protrusion of the abdominal contents and retain the reduced hernia within the abdominal cavity. It may be made from a variety or combination of various materials (e.g., elastic, canvas, or metallic). 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
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
00810178889778ViveSUP3159BLKXS2026-05-27
00810178889785ViveSUP3159BLKS2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840277405791Umbilical TapeRIVERPOINT MEDICAL, LLCEXM2024-10-08
00840277405807Umbilical TapeRIVERPOINT MEDICAL, LLCEXM2024-10-08
00840277405814Umbilical TapeRIVERPOINT MEDICAL, LLCEXM2024-10-08
10840277405798Umbilical TapeRIVERPOINT MEDICAL, LLCEXM2024-10-08
10840277405804Umbilical TapeRIVERPOINT MEDICAL, LLCEXM2024-10-08
10840277405811Umbilical TapeRIVERPOINT MEDICAL, LLCEXM2024-10-08
00810113576541ViveVIVE HEALTH LLCEXM2024-05-03
10790986000008CP Cotton Umbilical TapeC.P. MEDICAL CORPORATIONEXM2024-03-29
00790986000001CP Cotton Umbilical TapeC.P. MEDICAL CORPORATIONEXM2024-03-29
10790986000558CP Cotton Umbilical TapeC.P. MEDICAL CORPORATIONEXM2015-09-24
10790986000565CP Cotton Umbilical TapeC.P. MEDICAL CORPORATIONEXM2015-09-24
00790986000551CP Cotton Umbilical TapeC.P. MEDICAL CORPORATIONEXM2015-09-24
00790986000568CP Cotton Umbilical TapeC.P. MEDICAL CORPORATIONEXM2015-09-24
20790986000555CP Cotton Umbilical TapeC.P. MEDICAL CORPORATIONEXM2015-09-24