FDA.reportPublic FDA data

"COLDPACK NECK CONTOUR 23"" (IF NOT AVAIL USE 32188)"

Primary DI
00733657225105
Brand
"COLDPACK NECK CONTOUR 23"" (IF NOT AVAIL USE 32188)"
Company
ALIMED, INC.
Model
32707
Catalog number
2970000984
Published
2022-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
00733657225105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733657225105007336572251057336572251050733657225105

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

Contacts#

Phone, Email table
PhoneEmail
+1(781)329-2900customerservice@alimed.com

Regulatory Flags#

DUNS number
056007248
Device count
1
DM exempt
true
Premarket exempt
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00733657221923WRST ELASTIC FRDM LONG XXSM/RT572829700035922022-12-01
00733657221930WRST ELASTIC FRDM LONG XXSM/LF572929700035932022-12-01
00733657221947WRST ELASTIC FRDM LONG RT/XSM573029700035942022-12-01
00733657221954WRST ELASTIC FRDM LONG LF/XSM573129700035952022-12-01
00733657221961WRIST ELASTIC FRDM LONG RT/SM573229700035962022-12-01
00733657221978WRIST ELASTIC FRDM LONG LF/SM573329700035972022-12-01
00733657221985WRIST ELASTIC FRDM LONG RT/MD573429700035982022-12-01
00733657221992WRIST ELASTIC FRDM LONG LF/MD573529700035992022-12-01
00733657222005WRIST ELASTIC FRDM LONG RT/LG573629700036002022-12-01
00733657222012WRIST ELASTIC FRDM LONG LF/LG573729700036012022-12-01
00733657222029WRIST ELASTIC FRDM LONG RT/XLG573829700036022022-12-01
00733657222036WRIST ELASTIC FRDM LONG LF/XLG573929700036032022-12-01
00733657222074WRIST ELASTIC FRDM SHORT RT/XSM576029700036062022-12-01
00733657222081WRIST ELASTIC FRDM SHORT LF/XSM576129700036072022-12-01
00733657222098WRIST ELASTIC FRDM SHORT RT/SM576229700036082022-12-01
00733657222104WRIST ELASTIC FRDM SHORT LF/SM576329700036092022-12-01
00733657222111WRIST ELASTIC FRDM SHORT RT/MD576429700036102022-12-01
00733657222128WRIST ELASTIC FRDM SHORT LF/MD576529700036112022-12-01
00733657222135WRIST ELASTIC FRDM SHORT RT/LG576629700036122022-12-01
00733657222142WRIST ELASTIC FRDM SHORT LF/LG576729700036132022-12-01

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