FDA.reportPublic FDA data

First Aid Only

Primary DI
00738743007139
Brand
First Aid Only
Company
Acme United Corporation
Model
360649
Catalog number
360649
Device description
"Instant Hot Compress, 5.5"" x 7"""
Published
2022-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
00738743007139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00738743007139007387430071397387430071390738743007139

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

Contacts#

Phone, Email table
PhoneEmail
800 835 2263customerservice@acmeunited.com

Regulatory Flags#

DUNS number
001180207
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00092265917841First Aid Only917842026-04-23
00092265001472First Aid OnlyAN147AN1472021-08-10
00092265313179First Aid OnlyFAE-3131FAE-31312021-08-10
00073577900998First Aid Only90099-00290099-0022020-10-02
00092265100977First Aid Only10097100972020-10-02
00738743080309First Aid Only803080302020-12-11
00092265716086First Aid Only7116087116082020-10-06
00092265960021First Aid Only96002960022025-09-30
00092265508391First Aid OnlyM5083M50832022-01-21
00092265508490First Aid OnlyM5084M50842022-01-21
00092265508599First Aid OnlyM5085M50852022-01-21
00092265508698First Aid OnlyM5086M50862022-01-21
00092265508797First Aid OnlyM5087M50872022-01-21
00092265508896First Aid OnlyM5088M50882022-01-21
00738743210119First Aid Only21-01121-0112022-12-15
00092265022040First Aid OnlyB204B2042021-07-15
00738743961424Elite First Aid96142961422025-06-12
00738743961431Elite First Aid96143961432025-06-12
00092265002066First Aid OnlyAN206AN2062021-08-11
00092265022071First Aid OnlyB207B2072021-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00049696561518B.PUREFOURSTAR GROUP INC.IMD2026-06-09
00049696562102B.PUREFOURSTAR GROUP INC.IMD2026-06-09
08436587170522ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-18
08436587170010ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170027ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
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