FDA.reportPublic FDA data

Zhanzun

Primary DI
06975926256302
Brand
Zhanzun
Company
Anhui Zhanzun Industrial Co.,Ltd.
Model
9463 Pink
Published
2022-12-03
Public version status
Update
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
06975926256302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975926256302069759262563026975926256302

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
616180813
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975926253011Zhanzun9430 Grey2022-12-03
06975926253028Zhanzun9430 Light Blue2022-12-03
06975926253318Zhanzun9433 Grey2022-12-03
06975926253325Zhanzun9433 Light Blue2022-12-03
06975926253363Zhanzun9433 Red2022-12-03
06975926256326zhanzun9463 Blue2022-12-02
06975926256333Zhanzun9463 Green2022-12-02
06975926256340Zhanzun9463 Orange2022-12-02
06975926256357Zhanzun9463 Yellow2022-12-02
06975926256364Zhanzun9463 Red2022-12-02
06975926256371Zhanzun9463 Purple2022-12-03
06975926256388Zhanzun9463 White 2022-12-03
06975926256395Zhanzun9463 Dark Blue2022-12-03
06975926256609Zhanzun9466 Pink2022-12-03
06975926256616Zhanzun9466 Clear2022-12-03
06975926256623Zhanzun9466 Blue2022-12-03
06975926256630Zhanzun9466 Green2022-12-03
06975926256647Zhanzun9466 Orange2022-12-03
06975926256661Zhanzun9466 Red2022-12-03
06975926256678Zhanzun9466 Purple2022-12-03

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Primary DI, Brand, Company table
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00810178885954Arctic FlexVIVE HEALTH LLCIME2026-05-06
00840397513215Sharper ImageMerchsource, LLCIME2026-04-23
307073870439893M™3M COMPANYIME2026-04-21
307073870439963M™3M COMPANYIME2026-04-21
10735282287845MunchkinMUNCHKIN, INC.IME2026-03-18
00197998026133Solventum™Solventum US LLCIME2026-02-15
00197998026164Solventum™Solventum US LLCIME2026-02-15
00197998026614Solventum™Solventum US LLCIME2026-02-15
00810178884735ViveVIVE HEALTH LLCIME2025-12-05
00810113683065ManaEZ ROM Ice ShortManamed, Inc.IME2025-10-17
00810113683515ManaEZ Hip Ice CureTechManamed, Inc.IME2025-10-03
00810113683522ManaEZ ROM Ice CureTechManamed, Inc.IME2025-10-03
00810113683539ManaEZ Shoulder Ice CureTechManamed, Inc.IME2025-10-03
00810113683638Cold Compression Wrap, Pro-Ankle WrapManamed, Inc.IME2025-09-26
00810113683645Cold Compression Wrap, Pro-Back WrapManamed, Inc.IME2025-09-26
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00810113683669Cold Compression Wrap, Pro-Hip WrapManamed, Inc.IME2025-09-26
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