FDA.report

Freeze Sleeve

Primary DI
06974650930205
Brand
Freeze Sleeve
Company
Jiangsu Huanyi Industrial Co. LTD
Model
FS11102
Device description
Freeze Sleeve Black Small/Medium
Published
2023-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
06974650930205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06974650930205069746509302056974650930205

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
415186065
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
06974650930014Freeze SleeveFS100012023-07-14
06974650930021Freeze SleeveFS11102/FS100022023-07-14
06974650930038Freeze SleeveFS11103/FS100032023-07-14
06974650930045Freeze SleeveFS11104/FS100042023-07-14
06974650930052Freeze SleeveFS100052023-07-14
06974650930069Freeze SleeveFS100062023-07-14
06974650930076Freeze SleeveFS100252023-07-14
06974650930083Freeze SleeveFS100262023-07-14
06974650930090Freeze SleeveFS100272023-07-14
06974650930106Freeze SleeveFS100282023-07-14
06974650930113Freeze SleeveFS100292023-07-14
06974650930120Freeze SleeveFS100302023-07-14
06974650930137Freeze SleeveFS210012023-07-14
06974650930144Freeze SleeveFS210022023-07-14
06974650930151Freeze SleeveFS210032023-07-14
06974650930168Freeze SleeveFS210042023-07-14
06974650930175Freeze SleeveFS210052023-07-14
06974650930182Freeze SleeveFS210062023-07-14
06974650930199Freeze SleeveFS100312023-07-14
06974650930212Freeze SleeveFS111032023-07-14

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
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06973641884282CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
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06973641884336CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.IME2026-01-22
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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