FDA.report

Vive

Primary DI
10810041983241
Brand
Vive
Company
VIVE HEALTH LLC
Model
SUP2061BLKM
Device description
Knee Sleeve (Black) Medium
Published
2023-02-08
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

Related Records

Product Codes

CodeName
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)

Product Code Classifications

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810041983241PackageGS1100In Commercial Distribution
00810041983244PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004198324110810041983241
00810041983244008100419832448100419832440810041983244

GMDN Terms

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.

Sterilization Methods

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 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 DIBrandCompanyProduct codePublished
00636257211281MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211298MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211304MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211311MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211328MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211335MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211342MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211359MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211366MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211373MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211380MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211397MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211403MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211410MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211427MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211434MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211441MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211458MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211465MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211472MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211489MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211496MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211502MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257211519MEDIMEDI MANUFACTURING, INC.DWL2026-03-17
00636257206751MEDIMEDI MANUFACTURING, INC.DWL2026-03-06
00636257206768MEDIMEDI MANUFACTURING, INC.DWL2026-03-06
00636257206775MEDIMEDI MANUFACTURING, INC.DWL2026-03-06
00636257206782MEDIMEDI MANUFACTURING, INC.DWL2026-03-06
00636257206799MEDIMEDI MANUFACTURING, INC.DWL2026-03-06
00636257206805MEDIMEDI MANUFACTURING, INC.DWL2026-03-06