FDA.reportPublic FDA data

CRYOPUSH

Primary DI
06973641884213
Brand
CRYOPUSH
Company
Chengdu Cryo-push Medical Technology Co.,Ltd.
Model
Cold Wrap - Shoulder Wrap
Catalog number
KRP/FD-B3-M
Device description
Cold Wrap - Shoulder Wrap
Published
2026-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IMEPack, Hot Or Cold, Reusable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMEPack, Hot Or Cold, ReusablePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973641884213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973641884213069736418842136973641884213

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal hot/cold therapy pack, reusableA non-powered 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, nor is it designed to be dedicated to eye thermal therapy. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543049236
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973641886880CRYOPUSHKRP/MYY-B6-M2026-03-12
06973641886897CRYOPUSHKRP/MYY-E6-M2026-03-12
06973641886903CRYOPUSHKRP/MYY-C6-M2026-03-12
06973641886910CRYOPUSHKRP/MYY-H6-M2026-03-12
06973641886927CRYOPUSHKRP/MYY-A6-M2026-03-12
06973641886934CRYOPUSHKRP/MYY-T6-M2026-03-12
06973641886941CRYOPUSHKRP/MYY-F6-M2026-03-12
06973641886958CRYOPUSHKRP/MYY-G6-M2026-03-12
06973641887061CRYOPUSHKRP/MYY-M2026-03-12
06973641887078CRYOPUSHKRP/MYY-M2026-03-12
06973641887085CRYOPUSHKRP/MYY-M2026-03-12
06973641887092CRYOPUSHKRP/MYY-M2026-03-12
06973641887108CRYOPUSHKRP/MYY-M2026-03-12
06973641887115CRYOPUSHKRP/MYY-M2026-03-12
06973641887122CRYOPUSHKRP/MYY-M2026-03-12
06973641887139CRYOPUSHKRP/MYY-M2026-03-12
06973641887146CRYOPUSHKRP/MYY-M2026-03-12
06973641880017Medi GradeWaterproof Leg Cast & Bandage ProtectorKRP/FL-5304312026-02-25
06973641884206CRYOPUSHCold Wrap - Ankle WrapKRP/FD-A3-M2026-01-22
06973641884220CRYOPUSHCold Wrap -Thigh WrapKRP/FD-C3-M2026-01-22

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Primary DI, Brand, Company table
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00810113683676Cold Compression Wrap, Pro-Knee WrapManamed, Inc.IME2025-09-26
00810113683683Cold Compression Wrap, Pro-Shoulder WrapManamed, Inc.IME2025-09-26
00810113683706Cold Compression Wrap, Pro-Ankle Wrap-WLManamed, Inc.IME2025-09-26
00810113683713Cold Compression Wrap, Pro-Shoulder Wrap-WLManamed, Inc.IME2025-09-26
00810113683720Cold Compression Wrap, Pro-Knee Wrap-WLManamed, Inc.IME2025-09-26
00810113683737Cold Compression Wrap, Pro-Hip Wrap-WLManamed, Inc.IME2025-09-26
00810113683744Cold Compression Wrap, Pro-Back Wrap-WLManamed, Inc.IME2025-09-26
00850073571101American Hospital SupplyAmerican Hospital Supply LLCIME2025-07-28
00627394040018Pain CakesDrive Devilbiss HealthcareIME2025-06-03