Start-Up Kit Custom Luer 8700-0784-01

GUDID 00849111075336

6 foot tubing set including integral air trap chamber and stainless steel heat exchange coil

Zoll Circulation, Inc.

Intravascular heating/cooling system start kit Intravascular core temperature regulation system start kit Intravascular core temperature regulation system start kit Intravascular core temperature regulation system start kit Intravascular core temperature regulation system start kit Intravascular core temperature regulation system start kit Intravascular core temperature regulation system start kit Intravascular core temperature regulation system start kit Intravascular core temperature regulation system start kit Intravascular core temperature regulation system start kit Intravascular core temperature regulation system start kit Intravascular core temperature regulation system start kit Intravascular core temperature regulation system start kit Intravascular core temperature regulation system start kit Intravascular core temperature regulation system start kit Intravascular core temperature regulation system start kit Intravascular core temperature regulation system start kit
Primary Device ID00849111075336
NIH Device Record Key58772cc1-6e91-4910-8848-14a1b691511f
Commercial Distribution StatusIn Commercial Distribution
Brand NameStart-Up Kit Custom Luer
Version Model NumberCG-500D
Catalog Number8700-0784-01
Company DUNS799455241
Company NameZoll Circulation, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com
Phone4085412140
Emailudisj@zoll.com

Device Dimensions

Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet
Length6 Feet

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100849111075336 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NCXSystem, Hypothermia, Intravenous, Cooling

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-07-15

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