FDA.reportPublic FDA data

CARA

Primary DI
10038056000566
Brand
CARA
Company
CARA, INCORPORATED
Model
56
Published
2019-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10038056000566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1003805600056610038056000566

GMDN Terms#

Term, Definition table
TermDefinition
Hot therapy pack heating unitA mains electricity (AC-powered) device used to heat the contents of a reusable hot therapy pack to temperatures appropriate to apply heat therapy to the human body. This device, also known as a hydrocollator, typically consists of a stainless steel container, shelves, trays, or drawers that facilitate the heating and handling of the many hot therapy packs, and heating elements that heat the packs to a specified temperature so that the they are conditioned for reuse when needed. It is typically used in accident and emergency (A&E) rooms, rehabilitation facilities and for physiotherapy treatments.

Regulatory Flags#

DUNS number
101302412
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810025920876CARING MILLCRA542020-10-01
10038056000542Cara542019-02-15
10038056000559CARA552019-08-30
00854875008117CARING MILLCRA742019-08-30
10038056000504Cara502016-07-26
10038056000511Cara512016-07-26
10038056000528Cara522016-07-26
10038056000535Cara532016-07-26
10038056000702Cara702016-07-26
10038056000726Cara722016-07-26
10038056000733Cara732016-07-26
10038056000740Cara742018-04-23
00854875008056Caring MillCRA732018-08-22
00854875008063Caring MillCRA 512018-08-22

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Primary DI, Brand, Company table
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