Cool Line® Intravascular Heat Exchange Catheter Kit (Applause) 8700-0654-03

GUDID 00849111050074

The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter designed for placement in the central venous circulation from an insertion site in the jugular, subclavian, or femoral veins.

Zoll Circulation, Inc.

Intravascular heating/cooling system catheter
Primary Device ID00849111050074
NIH Device Record Key6c55b00c-0db1-4615-bf75-62044b7861bb
Commercial Distribution StatusIn Commercial Distribution
Brand NameCool Line® Intravascular Heat Exchange Catheter Kit (Applause)
Version Model NumberN/A
Catalog Number8700-0654-03
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

Device Dimensions

Catheter Gauge9.3 French
Catheter Gauge9.3 French
Length22 Centimeter
Catheter Gauge9.3 French
Length22 Centimeter
Catheter Gauge9.3 French
Length22 Centimeter
Catheter Gauge9.3 French
Length22 Centimeter
Catheter Gauge9.3 French
Length22 Centimeter
Catheter Gauge9.3 French
Length22 Centimeter
Catheter Gauge9.3 French
Length22 Centimeter
Catheter Gauge9.3 French
Length22 Centimeter
Catheter Gauge9.3 French
Length22 Centimeter
Catheter Gauge9.3 French
Length22 Centimeter
Catheter Gauge9.3 French
Length22 Centimeter
Catheter Gauge9.3 French
Length22 Centimeter
Catheter Gauge9.3 French
Length22 Centimeter
Catheter Gauge9.3 French
Length22 Centimeter
Catheter Gauge9.3 French
Length22 Centimeter
Catheter Gauge9.3 French
Length22 Centimeter
Catheter Gauge9.3 French

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
GS100849111050074 [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 Date2015-03-31

On-Brand Devices [Cool Line® Intravascular Heat Exchange Catheter Kit (Applause)]

00849111075060The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter design
00849111050074The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter design

Trademark Results [Cool Line]

Mark Image

Registration | Serial
Company
Trademark
Application Date
COOL LINE
COOL LINE
78751430 not registered Dead/Abandoned
Single Buoy Moorings Inc.
2005-11-10
COOL LINE
COOL LINE
77514164 3668415 Dead/Cancelled
Yamuna International
2008-07-03
COOL LINE
COOL LINE
75604187 2858190 Live/Registered
ZOLL CIRCULATION, INC.
1998-12-09

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