FDA.reportPublic FDA data

Cold Care Pack

Primary DI
00815212022883
Brand
Cold Care Pack
Company
Izi Medical Products, LLC
Model
CP1002
Published
2017-02-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
IMEPack, Hot Or Cold, Reuseable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMEPack, Hot Or Cold, ReusablePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815212022883PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815212022883008152120228838152120228830815212022883

GMDN Terms#

Term, Definition table
TermDefinition
Cold therapy pack chilling unitA mains electricity (AC-powered) device used to chill the contents of a reusable cold therapy pack or hot/cold therapy pack to temperatures appropriate to apply cold 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 chilling and handling of the many cold therapy packs, and chilling elements (e.g., integral coils) that create temperatures of around minus 17? Celsius. It is typically used in accident and emergency (A&E) rooms, rehabilitation facilities and for physiotherapy treatments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
933506164
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
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EIBA10020X-Mark100210022016-09-23
EIBA10070X-MArk100710072016-09-23
EIBA10080X-Mark100810082016-09-23
EIBA10090X-Mark100910092016-09-23
EIBA10210X-Mark102110212016-09-23
EIBA10220X-Mark102210222016-09-23
EIBA10230X-Mark102310232016-09-23
EIBA10270X-Mark102710272016-09-23
EIBA10280X-Mark102810282016-09-23
EIBA10290X-Mark102910292016-09-23
EIBA10400X-Mark104010402017-03-16
EIBA10410X-Mark104110412016-09-23
EIBA10420X-Mark104210422016-09-23
EIBA10470X-Mark104710472016-09-23
EIBA10600X-Mark Ultra106010602016-09-23
EIBA10610X-Mark Ultra106110612016-09-23
EIBA10620X-Mark Ultra106210622016-09-23
EIBA10670X-Mark Ultra106710672016-09-23

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