FDA.reportPublic FDA data

VIVE

Primary DI
00818323027884
Brand
VIVE
Company
VIVE HEALTH LLC
Model
LVA1016M4
Device description
Bed Underpad Medium 4-pack
Published
2019-05-03
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
EYQGarment, Protective, For Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYQGarment, Protective, For IncontinenceGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818323027881PackageGS16In Commercial Distribution
00818323027884PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081832302788110818323027881
00818323027884008183230278848183230278840818323027884

GMDN Terms#

Term, Definition table
TermDefinition
Waterproof bed mattress cover, reusableA device made of soft, waterproof material that is shaped to fit over a bed mattress to create a physical barrier to protect the mattress, prevent cross-contamination, and prevent exposure to soiling, typically bedwetting or spills of other liquids. It can be laundered for cleaning. 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
00810226442818ViveSUP3189BLK2026-10-01
00810226442788ViveLVA3082WHTGRY2026-09-30
00810226440944ViveCareRHB3080TAN462026-09-29
00810226440951ViveCareRHB3080TAN482026-09-29
00810226440968ViveCareRHB3080TAN4102026-09-29
00810226442542ViveCareRHB3080TAN46PAK12026-09-29
00810226442559ViveCareRHB3080TAN48PAK12026-09-29
00810226442566ViveCareRHB3080TAN410PAK12026-09-29
00810226442696ViveMOB1169BLK2026-09-29
00810178885329Vive CareRHB3071B10OZ2026-09-28
00810178889235ViveLVA3156BLK2026-09-28
00810178889280CoreTechSUP3128BLKS2026-05-05
00810178889297CoreTechSUP3128BLKM2026-05-05
00810178889303CoreTechSUP3128BLKL2026-05-05
00810178889310CoreTechSUP3128BLKXL2026-05-05
00810178889327CoreTechSUP3128BLK2XL2026-05-05
00810226442306ViveDMD1087CUFF2026-08-25
00810226442245ViveCSH1116GRY2026-08-21
00810226442290ViveLVA3188BLK2026-08-21
00810178889648CoreTechSUP3156BLK2026-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810065846433WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846440WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846457WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846464WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846471WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846488WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010177WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010184WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010191WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010207WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010214WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010221WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010658WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010665WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010672WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010689WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010696WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010702WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010719WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010726WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010733WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010740WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011501WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011518WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011525WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011532WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011549WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011556WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011563WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011570WeareverPRIME LIFE FIBERSEYQ2025-09-23