FDA.reportPublic FDA data

Vive

Primary DI
10810113573172
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
Rx
false
OTC
true
Sterile
false
Single use
false

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.

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
00810178883943ViveSUP3111BLK2026-03-06
00810178884506ViveMOB1141BLK322026-03-06
00810178884643ViveMOB1142BLK2026-03-06
00810178884766ViveMOB1144GRY2026-03-06
00810178884773ViveMOB1144BLU2026-03-06
00810178884780ViveMOB1144PNK2026-03-06
00810178885213ViveMOB1139BLK262026-03-06
00810178885220ViveMOB1139BLK282026-03-06
00810178885237ViveMOB1139BLK302026-03-06
00810178887040ViveLVA1004DBLU2026-03-06
00810178887057ViveLVA2030DBLU2026-03-06
00810178887392Vive MobilityMOB1079GRY2026-02-18
00810178886890ViveSUP2019BGEXS2026-02-17
00810178886906ViveSUP2019BGES2026-02-17
00810178886913ViveSUP2019BGEM2026-02-17
00810178886920ViveSUP2019BGEL2026-02-17
00810178886937ViveSUP2019BGEXL2026-02-17
00810178886944ViveSUP2019BLKXS2026-02-17
00810178886951ViveSUP2019BLKS2026-02-17
00810178886968ViveSUP2019BLKM2026-02-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06978521200046noneNingbo Huirui Technology Co., Ltd.KIA2025-04-11
06978521200053noneNingbo Huirui Technology Co., Ltd.KIA2025-04-11
06978521200060noneNingbo Huirui Technology Co., Ltd.KIA2025-04-11
06978521200077noneNingbo Huirui Technology Co., Ltd.KIA2025-04-11
20057475260945BIOS LivingThermor LtdKIA2024-08-19
20057475260952BIOS LivingThermor LtdKIA2024-08-19