FDA.reportPublic FDA data

VIVE

Primary DI
10818323026877
Brand
VIVE
Company
VIVE HEALTH LLC
Model
INS1012
Device description
Toe separator with bunion protector
Published
2019-03-07
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
FMPProtector, Skin Pressure
KNPOrthosis, Corrective Shoe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1
KNPOrthosis, Corrective ShoePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818323026877PackageGS1100In Commercial Distribution
00818323026870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081832302687710818323026877
00818323026870008183230268708183230268700818323026870

GMDN Terms#

Term, Definition table
TermDefinition
Orthotic insole, prefabricated, antimicrobialA prefabricated orthopaedic shoe insert intended to provide supplemental support for the arch and/or heel of the foot, whilst inhibiting microbes such as viruses, bacteria and fungi. It is typically made of fabric and/or synthetic polymer materials (e.g., wool, viscose, silicone gel, foam) impregnated with an antimicrobial substance, which is designed to resist extreme load and may provide thermal insulation. It is normally available [non-prescription] over-the-counter (OTC). 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
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
10603354600666TruVueEHOB INCFMP2025-03-20
10603354300696WAFFLEEHOB INCFMP2024-12-18
07613327632873Sage TAP LCSAGE PRODUCTS, LLCFMP2024-03-26
G096R9292209LineRising Eagle Medical LLCFMP2024-01-30
20845854082536Paradigm RevolutionConmed CorporationFMP2023-06-13
20845854082901Paradigm RevolutionConmed CorporationFMP2023-06-13
20845854082918Paradigm RevolutionConmed CorporationFMP2023-06-13
00609271000353KERRAPED PLUS™ All Purpose BootDarco (Europe) GmbHKNP2023-02-13
00609271000360KERRAPED PLUS™ All Purpose BootDarco (Europe) GmbHKNP2023-02-13
00609271000377KERRAPED PLUS™ All Purpose BootDarco (Europe) GmbHKNP2023-02-13
00609271000384KERRAPED PLUS™ All Purpose BootDarco (Europe) GmbHKNP2023-02-13
00609271000155DARCO® Commodus OpenDarco (Europe) GmbHKNP2023-02-08
00609271000162DARCO® Commodus OpenDarco (Europe) GmbHKNP2023-02-08
00609271000179DARCO® Commodus OpenDarco (Europe) GmbHKNP2023-02-08
00609271000186DARCO® Commodus OpenDarco (Europe) GmbHKNP2023-02-08
00609271000193DARCO® Commodus OpenDarco (Europe) GmbHKNP2023-02-08
00609271000254KERRAPED™ All Purpose BootDarco (Europe) GmbHKNP2023-02-08
00609271000261KERRAPED™ All Purpose BootDarco (Europe) GmbHKNP2023-02-08
00609271000278KERRAPED™ All Purpose BootDarco (Europe) GmbHKNP2023-02-08
00609271000285KERRAPED™ All Purpose BootDarco (Europe) GmbHKNP2023-02-08
00609271000902Health Design Classic Post Op ShoeDARCO INTERNATIONAL, INC.KNP2023-02-08
00609271000919Health Design Classic Post Op ShoeDARCO INTERNATIONAL, INC.KNP2023-02-08
00609271000926Health Design Classic Post Op ShoeDARCO INTERNATIONAL, INC.KNP2023-02-08
00609271000933Health Design Classic Post Op ShoeDARCO INTERNATIONAL, INC.KNP2023-02-08
00609271000940Health Design Classic Post Op ShoeDARCO INTERNATIONAL, INC.KNP2023-02-08
00609271000957Health Design Classic Post Op ShoeDARCO INTERNATIONAL, INC.KNP2023-02-08
00609271000964Health Design Classic Post Op ShoeDARCO INTERNATIONAL, INC.KNP2023-02-08
00609271000971Health Design Classic Post Op ShoeDARCO INTERNATIONAL, INC.KNP2023-02-08
00609271000988Health Design Classic Post Op ShoeDARCO INTERNATIONAL, INC.KNP2023-02-08
00609271001008Health Design EZY Close Post Op ShoeDARCO INTERNATIONAL, INC.KNP2023-02-08