FDA.reportPublic FDA data

Vive

Primary DI
00810113574455
Brand
Vive
Company
VIVE HEALTH LLC
Model
SUP3013BLKL2P
Device description
Abdominal Binder (2 Panel) Large
Published
2023-11-14
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
FQKBinder, Perineal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQKBinder, PerinealGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810113574452PackageGS120In Commercial Distribution
00810113574455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081011357445210810113574452
00810113574455008101135744558101135744550810113574455

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal binder, reusableA strip, roll or tube of fabric or polymer material intended to be applied to the abdomen to support relaxed abdominal walls (e.g., after surgery, during pregnancy) or to provide support for another device (e.g., dressing, ultrasound transducer, percutaneous lead). 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
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
00810113570365ViveVIVE HEALTH LLCFQK2023-11-14
00810113570372ViveVIVE HEALTH LLCFQK2023-11-14
00810113570389ViveVIVE HEALTH LLCFQK2023-11-14
00810113570396ViveVIVE HEALTH LLCFQK2023-11-14
00810113570402ViveVIVE HEALTH LLCFQK2023-11-14
00810113570419ViveVIVE HEALTH LLCFQK2023-11-14
00810113570426ViveVIVE HEALTH LLCFQK2023-11-14
00810113570433ViveVIVE HEALTH LLCFQK2023-11-14
00810113570440ViveVIVE HEALTH LLCFQK2023-11-14
00810113570457ViveVIVE HEALTH LLCFQK2023-11-14
00810113570464ViveVIVE HEALTH LLCFQK2023-11-14
00810113570471ViveVIVE HEALTH LLCFQK2023-11-14
00810113574431ViveVIVE HEALTH LLCFQK2023-11-14
00810113574448ViveVIVE HEALTH LLCFQK2023-11-14
00810113574462ViveVIVE HEALTH LLCFQK2023-11-14
00810113574479ViveVIVE HEALTH LLCFQK2023-11-14
10810113570362ViveVIVE HEALTH LLCFQK2023-11-14
10810113570379ViveVIVE HEALTH LLCFQK2023-11-14
10810113570386ViveVIVE HEALTH LLCFQK2023-11-14
10810113570393ViveVIVE HEALTH LLCFQK2023-11-14
10810113570409ViveVIVE HEALTH LLCFQK2023-11-14
10810113570416ViveVIVE HEALTH LLCFQK2023-11-14
10810113570423ViveVIVE HEALTH LLCFQK2023-11-14
10810113570430ViveVIVE HEALTH LLCFQK2023-11-14
10810113570447ViveVIVE HEALTH LLCFQK2023-11-14
10810113570454ViveVIVE HEALTH LLCFQK2023-11-14
10810113570461ViveVIVE HEALTH LLCFQK2023-11-14
10810113570478ViveVIVE HEALTH LLCFQK2023-11-14
10810113574438ViveVIVE HEALTH LLCFQK2023-11-14
10810113574445ViveVIVE HEALTH LLCFQK2023-11-14