FDA.reportPublic FDA data

Vive

Primary DI
00810041983251
Brand
Vive
Company
VIVE HEALTH LLC
Model
SUP2061BLKL
Device description
Knee Sleeves (Black) Large
Published
2023-02-08
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
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)General Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810041983258PackageGS1100In Commercial Distribution
00810041983251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004198325810810041983258
00810041983251008100419832518100419832510810041983251

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure tubular garmentA device in the form of a tube intended to tightly fit over and apply compression/pressure (i.e., graduated or even-force) to a part of a limb, typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)], to control scarring, and/or to manage lymphoedema; it is neither a strip/roll binder, glove, sock/stocking, nor tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex); it does not include antimicrobial features. 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
00810178883127ViveSUP3108S2026-07-21
00810178883134ViveSUP3108M2026-07-21
00810178883141ViveSUP3108L2026-07-21
00810178883158ViveSUP3108XL2026-07-21
00810226441217ViveLVA3173WOOD2026-07-21
00810226441224SuresLVA3174BFL2026-07-21
00810226441231SuresLVA3174BLK2026-07-21
00810226441248SuresLVA3174RPF2026-07-21
00810178889334SuresLVA2040NAV2026-07-17
00810178889341SuresLVA2040NAV2PAK2026-07-17
00810178889358SuresLVA2040NAV4PAK2026-07-17
00810226441156SuresLVA2040BLK2026-07-17
00810226441163SuresLVA2040BLK2PAK2026-07-17
00810226441170SuresLVA2040BLK4PAK2026-07-17
00810226441187SuresLVA2040TAN2026-07-17
00810226441194SuresLVA2040TAN2PAK2026-07-17
00810226441200SuresLVA2040TAN4PAK2026-07-17
00810226440593CoreTechSUP31702026-07-16
00818323020014ViveLVA10412026-07-16
00810226440623ViveSUP3168BGES2026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810226440623ViveVIVE HEALTH LLCDWL2026-07-14
00810226440630ViveVIVE HEALTH LLCDWL2026-07-14
00810226440647ViveVIVE HEALTH LLCDWL2026-07-14
00810226440654ViveVIVE HEALTH LLCDWL2026-07-14
00810226440661ViveVIVE HEALTH LLCDWL2026-07-14
00810226440678ViveVIVE HEALTH LLCDWL2026-07-14
00810226440685ViveVIVE HEALTH LLCDWL2026-07-14
00810226440692ViveVIVE HEALTH LLCDWL2026-07-14
00810226440708ViveVIVE HEALTH LLCDWL2026-07-14
00810226440715ViveVIVE HEALTH LLCDWL2026-07-14
00810226440739ViveVIVE HEALTH LLCDWL2026-07-14
00810226440746ViveVIVE HEALTH LLCDWL2026-07-14
00810226440753ViveVIVE HEALTH LLCDWL2026-07-14
00810226440760ViveVIVE HEALTH LLCDWL2026-07-14
00810226440777ViveVIVE HEALTH LLCDWL2026-07-14
00810226440784ViveVIVE HEALTH LLCDWL2026-07-14
00810226440791ViveVIVE HEALTH LLCDWL2026-07-14
00810226440807ViveVIVE HEALTH LLCDWL2026-07-14
00810226440814ViveVIVE HEALTH LLCDWL2026-07-14
00810226440821ViveVIVE HEALTH LLCDWL2026-07-14
00048503515379Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515386Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515393Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515416Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515423Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515430Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515447Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515454Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515461Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515478Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22