FDA.reportPublic FDA data

DISPOSABLE HOT OR COLD PACK COVER

Primary DI
06950471300137
Brand
DISPOSABLE HOT OR COLD PACK COVER
Company
Hangzhou A-Tek Medical & Textiles Co., Ltd.
Model
28030
Device description
DISPOSABLE HOT OR COLD PACK COVER, USED TO COVER THE ICE PACK OR HOT PACK
Published
2023-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
IMDPack, Hot Or Cold, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMDPack, Hot Or Cold, DisposablePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06950471300137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06950471300137069504713001376950471300137

GMDN Terms#

Term, Definition table
TermDefinition
Hot/cold therapy pack, single-useA 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, peat) 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 single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
547874292
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06950471300144VACUUM COLLECTION BOTTLE280312023-07-21
06950471300151GAS COLLECTING VESSEL280322023-07-21
06950471300038DISPOSABLE BEDDING PRODUCTS280202023-07-18
06950471300045EXAMINATION GOWN280212023-07-18
06950471300052SURGICAL CAP280222023-07-18
06950471300069SURGICAL APPAREL ACCESSORY280232023-07-18
06950471300076OPERATING-ROOM SHOE COVER280242023-07-18
06950471300083SURGICAL GOWN280252023-07-18
06950471300106NON-SURGICAL ISOLATION GOWN280272023-07-18
06950471300113TABLE TRAY FOR OPERATING ROOM280282023-07-18
06950471300120CONDUCTIVE SHOE AND SHOE COVER280292023-07-18
06950471320067RESUABLE INCONTINENCE UNDERPAD280192023-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08436587170522ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-18
08436587170010ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
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08436587170065ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170102ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170225ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170232ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170249ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170362ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170386ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170553ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170560ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170577ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170638ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170812ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170843ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170867ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170942ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170966ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170973ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171017ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171031ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171208ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171253ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171284ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171314ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171338ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171352ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171505ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171666ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15