FDA.reportPublic FDA data

Vive

Primary DI
00810113573175
Brand
Vive
Company
VIVE HEALTH LLC
Model
RHB2107SCLR
Device description
Short Lightweight Leg Cast Cover
Published
2023-08-02
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
KIACover, Cast

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIACover, CastGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810113573172PackageGS1192In Commercial Distribution
00810113573175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081011357317210810113573172
00810113573175008101135731758101135731750810113573175

GMDN Terms#

Term, Definition table
TermDefinition
Cast/bandage waterproof bathing cover, reusableA device made of waterproof materials designed to be placed over a treated area of the body, typically a plaster cast, stitches, bandage, dressing, or PICC line, to keep the area dry while the user is having a shower or a bath. 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
00810226440487ViveSUP3167GRYXS2026-07-13
00810226440494ViveSUP3167GRYS2026-07-13
00810226440500ViveSUP3167GRYM2026-07-13
00810226440517ViveSUP3167GRYL2026-07-13
00810226440524ViveSUP3167GRYXL2026-07-13
00810226440531ViveSUP3167BGEXS2026-07-13
00810226440548ViveSUP3167GRYS2026-07-13
00810226440555ViveSUP3167GRYM2026-07-13
00810226440562ViveSUP3167GRYL2026-07-13
00810226440579ViveSUP3167GRYXL2026-07-13
00810226441019ViveSoleINS1014PUR2026-07-13
00810226441026ViveSoleINS1014PURS2026-07-13
00810226441002ViveLVA3171WHT2026-07-08
00818323025538ViveMOB1025BLU2019-03-07
00818323025545ViveMOB1025SLV2019-03-07
00810178887750Vive PrecisionDMD1097O28G2026-06-26
00810178887767Vive PrecisionDMD1097O30G2026-06-26
00810178889952ViveLVA3163BLK2026-06-10
00810226440104ViveLVA3167BLK2026-06-04
00810226440111ViveLVA3167BLKPAK22026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178889976ViveVIVE HEALTH LLCKIA2026-06-03
00810178889983ViveVIVE HEALTH LLCKIA2026-06-03
00810178889990ViveVIVE HEALTH LLCKIA2026-06-03
00810226440005ViveVIVE HEALTH LLCKIA2026-06-03
00810226440012ViveVIVE HEALTH LLCKIA2026-06-03
00810226440029ViveVIVE HEALTH LLCKIA2026-06-03
06973641880017Medi GradeChengdu Cryo-push Medical Technology Co.,Ltd.KIA2026-02-25
00850063404198easycareSynchronis Medical, LLCKIA2026-01-29
00850063404204easycareSynchronis Medical, LLCKIA2026-01-29
00850063404211easycareSynchronis Medical, LLCKIA2026-01-29
00850063404228easycareSynchronis Medical, LLCKIA2026-01-29
00850063404235easycareSynchronis Medical, LLCKIA2026-01-29
00850063404242easycareSynchronis Medical, LLCKIA2026-01-29
00850063404259easycareSynchronis Medical, LLCKIA2026-01-29
00850063404266easycareSynchronis Medical, LLCKIA2026-01-29
00850063404273easycareSynchronis Medical, LLCKIA2026-01-29
00850063404280easycareSynchronis Medical, LLCKIA2026-01-29
00850063404358easycareSynchronis Medical, LLCKIA2026-01-29
00850063404297easycareSynchronis Medical, LLCKIA2026-01-23
00850063404303easycareSynchronis Medical, LLCKIA2026-01-23
00850063404310easycareSynchronis Medical, LLCKIA2026-01-23
00850063404327easycareSynchronis Medical, LLCKIA2026-01-23
00850063404334easycareSynchronis Medical, LLCKIA2026-01-23
00850063404341easycareSynchronis Medical, LLCKIA2026-01-23
00850063404365easycareSynchronis Medical, LLCKIA2026-01-23
10618125192318AquaGuardTIDI PRODUCTS, LLCKIA2025-09-23
06978521200008noneNingbo Huirui Technology Co., Ltd.KIA2025-04-11
06978521200015noneNingbo Huirui Technology Co., Ltd.KIA2025-04-11
06978521200022noneNingbo Huirui Technology Co., Ltd.KIA2025-04-11
06978521200039noneNingbo Huirui Technology Co., Ltd.KIA2025-04-11