ICY® Intravascular Heat Exchange Catheter Kit Applause (Heparin) 8700-0657-01

GUDID 00849111075084

The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

Zoll Circulation, Inc.

Intravascular heating/cooling system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter Intravascular core temperature regulation system catheter

• Primary Device ID: 00849111075084
• NIH Device Record Key: 92bbe5e7-2438-4e19-8b54-d9e2633552ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICY® Intravascular Heat Exchange Catheter Kit Applause (Heparin)
• Version Model Number: IC-3893
• Catalog Number: 8700-0657-01
• 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: 38 Centimeter
• Catheter Gauge: 9.3 French
• Length: 38 Centimeter
• Catheter Gauge: 9.3 French
• Length: 38 Centimeter
• Catheter Gauge: 9.3 French
• Length: 38 Centimeter
• Catheter Gauge: 9.3 French
• Length: 38 Centimeter
• Catheter Gauge: 9.3 French
• Length: 38 Centimeter
• Catheter Gauge: 9.3 French
• Length: 38 Centimeter
• Catheter Gauge: 9.3 French
• Length: 38 Centimeter
• Catheter Gauge: 9.3 French
• Length: 38 Centimeter
• Catheter Gauge: 9.3 French
• Length: 38 Centimeter
• Catheter Gauge: 9.3 French
• Length: 38 Centimeter
• Catheter Gauge: 9.3 French
• Length: 38 Centimeter
• Catheter Gauge: 9.3 French
• Length: 38 Centimeter
• Catheter Gauge: 9.3 French
• Length: 38 Centimeter
• Catheter Gauge: 9.3 French
• Length: 38 Centimeter
• Catheter Gauge: 9.3 French
• Length: 38 Centimeter
• Catheter Gauge: 9.3 French

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849111075084 [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

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