FDA.report

Vive

Primary DI
10818323028833
Brand
Vive
Company
VIVE HEALTH LLC
Model
SUP2012GRY
Device description
Back Ice Wrap
Published
2023-02-06
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
IMEPack, Hot Or Cold, Reusable

Product Code Classifications

CodeDeviceSpecialtyClass
IMEPack, Hot Or Cold, ReusablePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10818323028833PackageGS16In Commercial Distribution
00818323028836PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081832302883310818323028833
00818323028836008183230288368183230288360818323028836

GMDN Terms

TermDefinition
Hot/cold therapy pack, reusableA non-sterile device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck. 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
00197998026140Solventum™Solventum US LLCIME2026-02-15
00197998026171Solventum™Solventum US LLCIME2026-02-15
00197998026621Solventum™Solventum US LLCIME2026-02-15
00197998320255Solventum™Solventum US LLCIME2026-02-15
00810178881840Arctic FlexVIVE HEALTH LLCIME2026-02-05
00818323024869Arctic FlexVIVE HEALTH LLCIME2026-02-03
00885914107898Sammons PrestonPerformance Health Supply, LLCIME2026-01-23
06973641884206CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884213CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
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06973641884244CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884251CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884268CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884275CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884282CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884299CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884305CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884312CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884329CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884336CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884343CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
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06973641884374CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884381CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884398CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884404CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884411CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
06973641884428CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22