truFreeze 20-00181

GUDID 00857068006075

16 Fr. Active Venting Cryo Decompression Tube (Low Durometer)

Csa Medical, Inc.

General cryosurgical system, cryogen gas, mechanical
Primary Device ID00857068006075
NIH Device Record Key68421bae-88b5-4ed6-bcab-2b61358f3e6b
Commercial Distribution StatusIn Commercial Distribution
Brand NametruFreeze
Version Model Number20-00181
Catalog Number20-00181
Company DUNS621229413
Company NameCsa Medical, 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com
Phone1-866-481-7786
Emailservice@csamedical.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry / Away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100857068006075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEHUnit, Cryosurgical, Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


[00857068006075]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-09-26

On-Brand Devices [truFreeze]

00857068006112Active Venting Catheter Qty 1
00857068006105Rapid AV Catheter
00857068006099Rapid Av Active Venting Spray Kit - 5 Rapid AV Catheters, 5 Active Venting 16 Fr LD CDT
0085706800608216 Fr Active Venting Kit. 5 - 16 Fr Active Venting Cryo Decompression Tube (Low Durometer) 5 -
0085706800607516 Fr. Active Venting Cryo Decompression Tube (Low Durometer)
0085706800606816 Fr. Active Venting Kit 5 16 Fr. Active Venting Cryo Decompression Tube 5 Active Venting Cathe
0085706800605116 Fr. Active Venting Cryo Decompression Tube
00857068006044Active Venting Spray Kit 5 Active Venting Cryo Decompression Tube 5 Active Venting Catheter
00857068006037Active Venting Cryo Decompression Tube
00857068006020Active Venting Catheter
00857068006013Passive Venting Catheter
00857068006006truFreeze Console
00857068006143Rapid AV Kit with 20 Fr CDT (5 pack)
10857068006119Box of 5 Active Venting Catheters
10857068006102Rapid AV Catheter, box of 5
1085706800605816 Fr. Active Venting Cryo Decompression Tube Box of 5
10857068006034Box of 5 Active Venting Cryo Decompression Tubes
10857068006027Box of 5 Active Venting Catheters
10857068006010Box of 5 Passive Venting Catheters
1085706800607216 Fr Active Venting Cryo Decompression Tube (Low Durometer), Box of 5

Trademark Results [truFreeze]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRUFREEZE
TRUFREEZE
77813346 3891062 Live/Registered
CSA MEDICAL, INC.
2009-08-26
TRUFREEZE
TRUFREEZE
77813330 3891061 Live/Registered
CSA MEDICAL, INC.
2009-08-26

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