FDA.reportPublic FDA data

Vive

Primary DI
00810113573151
Brand
Vive
Company
VIVE HEALTH LLC
Model
RHB2106SCLR
Device description
Short Lightweight Arm 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
00810113573151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810113573151008101135731518101135731510810113573151

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.

Sterilization Methods#

Method table
Method

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
00810226440104ViveLVA3167BLK2026-06-04
00810226440111ViveLVA3167BLKPAK22026-06-04
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

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