Cool Line® Intravascular Heat Exchange Catheter Kit (Applause) 8700-0654-40

GUDID 00849111075060

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.

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• Primary Device ID: 00849111075060
• NIH Device Record Key: d648d176-2db5-4a09-976d-87e641d7be26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cool Line® Intravascular Heat Exchange Catheter Kit (Applause)
• Version Model Number: CL-2295AE
• Catalog Number: 8700-0654-40
• Company DUNS: 799455241
• Company Name: Zoll Circulation, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: false
• 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: 9.3 French
• Catheter Gauge: 9.3 French
• Length: 22 Centimeter
• Catheter Gauge: 9.3 French
• Length: 22 Centimeter
• Catheter Gauge: 9.3 French
• Length: 22 Centimeter
• Catheter Gauge: 9.3 French
• Length: 22 Centimeter
• Catheter Gauge: 9.3 French
• Length: 22 Centimeter
• Catheter Gauge: 9.3 French
• Length: 22 Centimeter
• Catheter Gauge: 9.3 French
• Length: 22 Centimeter
• Catheter Gauge: 9.3 French
• Length: 22 Centimeter
• Catheter Gauge: 9.3 French
• Length: 22 Centimeter
• Catheter Gauge: 9.3 French
• Length: 22 Centimeter
• Catheter Gauge: 9.3 French
• Length: 22 Centimeter
• Catheter Gauge: 9.3 French
• Length: 22 Centimeter
• Catheter Gauge: 9.3 French
• Length: 22 Centimeter
• Catheter Gauge: 9.3 French
• Length: 22 Centimeter
• Catheter Gauge: 9.3 French
• Length: 22 Centimeter
• Catheter Gauge: 9.3 French
• Length: 22 Centimeter
• Catheter Gauge: 9.3 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849111075060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101987

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: 2015-03-31

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

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