FDA.report

Cold Care Pack

Primary DI
00815212022005
Brand
Cold Care Pack
Company
Izi Medical Products, LLC
Model
S-CP1002-1
Published
2017-02-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
IMEPack, Hot Or Cold, Reuseable

Product Code Classifications

CodeDeviceSpecialtyClass
IMEPack, Hot Or Cold, ReusablePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815212022005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815212022005008152120220058152120220050815212022005

GMDN Terms

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

Regulatory Flags

DUNS number
933506164
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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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