C2 CryoBalloon Cartridge, Regular FG-1010

GUDID 00854924006101

C2 CryoBalloon Cartridge, Regular, for C2 CryoBalloon Ablation System

C2 THERAPEUTICS, INC.

High-pressure medical gas tubing
Primary Device ID00854924006101
NIH Device Record Key1d301c96-bcbd-44fd-8846-42dbc2880f12
Commercial Distribution StatusIn Commercial Distribution
Brand NameC2 CryoBalloon Cartridge, Regular
Version Model NumberFG-1010
Catalog NumberFG-1010
Company DUNS929139249
Company NameC2 THERAPEUTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 Degrees Kelvin and 106 Degrees Kelvin
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 Degrees Kelvin and 106 Degrees Kelvin
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 Degrees Kelvin and 106 Degrees Kelvin
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 Degrees Kelvin and 106 Degrees Kelvin
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 Degrees Kelvin and 106 Degrees Kelvin
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 Degrees Kelvin and 106 Degrees Kelvin
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 Degrees Kelvin and 106 Degrees Kelvin
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 Degrees Kelvin and 106 Degrees Kelvin
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100854924006101 [Primary]

FDA Product Code

GEHUnit, Cryosurgical, Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-10-19

Devices Manufactured by C2 THERAPEUTICS, INC.

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00854924006163 - BOA Endoscopic Valve2018-07-06 BOA Endoscopic Valve, Endoscopic Accessory
00854924006170 - C2 CryoBalloon2018-07-06 Controller
00854924006187 - C2 CryoBalloon2018-07-06 Foot Pedal
00854924006323 - C2 CryoBalloon Full 8 Catheter2018-07-06 C2 CryoBalloon Full 8 Catheter for C2 CryoBalloon Ablation System
00854924006330 - C2 CryoBalloon Focal Pear Catheter 2018-07-06 C2 CryoBalloon Focal Pear Catheter for C2 CryoBalloon Ablation System
00854924006248 - C2 CryoBalloon2018-04-26 Pear Catheter Focal
00854924006262 - C2 CryoBalloon2018-04-26 90 Pear Catheter

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