FDA.report

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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
IMDPack, Hot Or Cold, Disposable

Product Code Classifications

CodeDeviceSpecialtyClass
IMDPack, Hot Or Cold, DisposablePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00738743007139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00738743007139007387430071397387430071390738743007139

GMDN Terms

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

Contacts

PhoneEmail
800 835 2263customerservice@acmeunited.com

Regulatory Flags

DUNS number
001180207
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00092265914031First Aid Only91403914032022-09-09
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00092265914055First Aid Only91405914052022-09-09
00738743002608First Aid Only36693CV36693CV2022-09-09
00738743002721First Aid Only5011715011712022-09-09
00738743006507First Aid OnlyDX0401MDX0401M2022-09-09
00092265913256First Aid Only91325913252022-08-26
00092265913263First Aid Only91326913262022-08-26

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