Start-Up Kit Extended Length, Custom Luer 8700-0785-01

GUDID 00849111075350

9 foot tubing set including integral air trap chamber and stainless steel heat exchange coil

Zoll Circulation, Inc.

Intravascular heating/cooling system start kit

• Primary Device ID: 00849111075350
• NIH Device Record Key: 69505a21-5a01-49e4-a457-355c2fcd9be1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Start-Up Kit Extended Length, Custom Luer
• Version Model Number: CG-500D EX
• Catalog Number: 8700-0785-01
• 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

• Length: 9 Feet
• Length: 9 Feet
• Length: 9 Feet
• Length: 9 Feet
• Length: 9 Feet
• Length: 9 Feet
• Length: 9 Feet
• Length: 9 Feet
• Length: 9 Feet
• Length: 9 Feet
• Length: 9 Feet
• Length: 9 Feet
• Length: 9 Feet
• Length: 9 Feet
• Length: 9 Feet
• Length: 9 Feet
• Length: 9 Feet

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849111075350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K014241

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: 2015-07-15

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