FDA.report

Vive

Primary DI
10810041987201
Brand
Vive
Company
VIVE HEALTH LLC
Model
RHB2018XL
Device description
Compression Gloves Pink (XL)
Published
2022-07-15
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
ITQJoint, Knee, External Brace
MHWDressing, Compression

Product Code Classifications

CodeDeviceSpecialtyClass
ITQJoint, Knee, External BracePhysical Medicine1
MHWDressing, CompressionGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810041987201PackageGS1100In Commercial Distribution
00810041987204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004198720110810041987201
00810041987204008100419872048100419872040810041987204

GMDN Terms

TermDefinition
Compression/pressure gloveA device in the form of a short or long glove intended to tightly fit over the hand(s) to apply compression/pressure (i.e., graduated or even-force), typically to control oedema, swelling and/or scarring due to arthritis or injuries, and/or to manage lymphoedema; it is not a strip/roll binder, shirt or tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex) and may be available with openings for fingers and/or with integrated sleeves that may reach the wrist, elbow, or axilla; 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
00851587006097AirWrap XLRevmedx, Inc.MHW2026-02-25
00810178886890ViveVIVE HEALTH LLCMHW2026-02-17
00810178886906ViveVIVE HEALTH LLCMHW2026-02-17
00810178886913ViveVIVE HEALTH LLCMHW2026-02-17
00810178886920ViveVIVE HEALTH LLCMHW2026-02-17
00810178886937ViveVIVE HEALTH LLCMHW2026-02-17
00810178886944ViveVIVE HEALTH LLCMHW2026-02-17
00810178886951ViveVIVE HEALTH LLCMHW2026-02-17
00810178886968ViveVIVE HEALTH LLCMHW2026-02-17
00810178886975ViveVIVE HEALTH LLCMHW2026-02-17
00810178886982ViveVIVE HEALTH LLCMHW2026-02-17
00810178886999ViveVIVE HEALTH LLCMHW2026-02-17
00810178887002ViveVIVE HEALTH LLCMHW2026-02-17
00810178887019ViveVIVE HEALTH LLCMHW2026-02-17
00810178887026ViveVIVE HEALTH LLCMHW2026-02-17
00810178887033ViveVIVE HEALTH LLCMHW2026-02-17
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