FDA.reportPublic FDA data

VIVE

Primary DI
10810041981094
Brand
VIVE
Company
VIVE HEALTH LLC
Model
SUP2027
Device description
1843 OA Knee Brace
Published
2020-01-09
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
ITQJoint, Knee, External Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITQJoint, Knee, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810041981094PackageGS11In Commercial Distribution
00810041981097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004198109410810041981094
00810041981097008100419810978100419810970810041981097

GMDN Terms#

Term, Definition table
TermDefinition
Hip/knee orthosisAn externally applied orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the hip and knee. 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
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
00057475210434BIOS LivingThermor LtdITQ2023-03-31
0060927120013516'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120015916'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120017316'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120018016'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120019716'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120033320'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120035720'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120037120'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120038820'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120039520'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927121050920'' DLX 3-PANEL KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927121060820'' DLX 3-PANEL KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927121080620'' DLX 3-PANEL KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610774"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (small)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610781"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (medium)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610798"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610804"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (x-large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610811"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (small)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610828"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (medium)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610835"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610842"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (x-large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610859"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (xx-large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610866"Knee Immobilizer, Super-Lite, Contoured Stay, 20"" (small)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610873"Knee Immobilizer, Super-Lite, Contoured Stay, 20"" (x-large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610880"Knee Immobilizer, Super-Lite, Contoured Stay, 20"" (xx-large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610897"Knee Immobilizer, Super-Lite, Contoured Stay, 24"" (small)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610903"Knee Immobilizer, Super-Lite, Contoured Stay, 24"" (medium)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610910"Knee Immobilizer, Super-Lite, Contoured Stay, 24"" (large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08
00609271610927"Knee Immobilizer, Super-Lite, Contoured Stay, 24"" (x-large)"DARCO INTERNATIONAL, INC.ITQ2023-02-08