Quattro, Japan, Final Packaged Kit (Applause)

GUDID 00849111050050

Zoll Circulation, Inc.

Intravascular heating/cooling system catheter
Primary Device ID00849111050050
NIH Device Record Keya060d6c5-3011-4635-9f53-8167388e92e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuattro, Japan, Final Packaged Kit (Applause)
Version Model NumberIC-4593
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

Catheter Gauge9.3 French
Catheter Gauge9.3 French
Length45 Centimeter
Catheter Gauge9.3 French
Length45 Centimeter
Catheter Gauge9.3 French
Length45 Centimeter
Catheter Gauge9.3 French
Length45 Centimeter
Catheter Gauge9.3 French
Length45 Centimeter
Catheter Gauge9.3 French
Length45 Centimeter
Catheter Gauge9.3 French
Length45 Centimeter
Catheter Gauge9.3 French
Length45 Centimeter
Catheter Gauge9.3 French
Length45 Centimeter
Catheter Gauge9.3 French
Length45 Centimeter
Catheter Gauge9.3 French
Length45 Centimeter
Catheter Gauge9.3 French
Length45 Centimeter
Catheter Gauge9.3 French
Length45 Centimeter
Catheter Gauge9.3 French
Length45 Centimeter
Catheter Gauge9.3 French
Length45 Centimeter
Catheter Gauge9.3 French
Length45 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
GS100849111050050 [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 Date2016-10-10

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00849111076135 - Thermogard™ Vest, L/XL2024-05-30 Thermogard™ Vest, L/XL
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