InnerCool RTx 14F Standard Catheter 8700-000823-01

GUDID 00849111075398

An endovascular catheter having a heat exchange element at the distal end, through which a thermal transfer fluid is circulated to cool or warm the blood, and which has 14 Fr diameter.

Zoll Circulation, Inc.

Intravascular heating/cooling system catheter

• Primary Device ID: 00849111075398
• NIH Device Record Key: 411c0c57-8cee-4ab7-8a5a-470111bc1052
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InnerCool RTx 14F Standard Catheter
• Version Model Number: NA
• Catalog Number: 8700-000823-01
• Company DUNS: 799455241
• Company Name: Zoll Circulation, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com
• Phone: 4085412140
• Email: udisj@zoll.com

Device Dimensions

• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Length: 65 Centimeter
• Catheter Gauge: 14 French
• Length: 65 Centimeter
• Catheter Gauge: 14 French
• Length: 65 Centimeter
• Catheter Gauge: 14 French
• Length: 65 Centimeter
• Catheter Gauge: 14 French
• Length: 65 Centimeter
• Catheter Gauge: 14 French
• Length: 65 Centimeter
• Catheter Gauge: 14 French
• Length: 65 Centimeter
• Catheter Gauge: 14 French
• Length: 65 Centimeter
• Catheter Gauge: 14 French
• Length: 65 Centimeter
• Catheter Gauge: 14 French
• Length: 65 Centimeter
• Catheter Gauge: 14 French
• Length: 65 Centimeter
• Catheter Gauge: 14 French
• Length: 65 Centimeter
• Catheter Gauge: 14 French
• Length: 65 Centimeter
• Catheter Gauge: 14 French
• Length: 65 Centimeter
• Catheter Gauge: 14 French
• Length: 65 Centimeter
• Catheter Gauge: 14 French
• Length: 65 Centimeter
• Catheter Gauge: 14 French

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849111075398 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080908

FDA Product Code

• NCX: System, Hypothermia, Intravenous, Cooling

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-07-01

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