14F PACKAGED ACCUTROL CATHETER 8700-000825-01

GUDID 00849111075411

The InnerCool Accutrol® Catheter contains an integrated thermistor for temperature feedback and control that eliminates the need for an independently placed temperature-monitoring probe. The Catheter has a polymeric catheter shaft with a radio-opaque flexible distal metallic Temperature Control Element (TCE).

Zoll Circulation, Inc.

Intravascular heating/cooling system catheter

• Primary Device ID: 00849111075411
• NIH Device Record Key: 8ed90c41-c11f-4bf4-b3d1-f2d3ebef5ae5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 14F PACKAGED ACCUTROL CATHETER
• Version Model Number: NA
• Catalog Number: 8700-000825-01
• 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: 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: 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	00849111075411 [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

Devices Manufactured by Zoll Circulation, Inc.

• 00849111076098 - STX SURFACE COOLING: 2024-08-23 STX Surface Cooling Pad
• 00849111076104 - STX SURFACE COOLING: 2024-08-23 STX SURFACE COOLING Pad L/XL PAD SET
• 00849111076111 - STX SURFACE COOLING: 2024-08-23 STX SURFACE COOLING Pad THIGHS ONLY PAD SET
• 00849111076074 - Thermogard HQ Surface Start-Up Kit: 2024-05-30 The Surface Start-Up Kit is a tubing set that connects the Thermogard XP® console to a STx™ Vest or Thermogard™ Vest surfac
• 00849111076081 - ThermoGard XP Surface Start-Up Kit: 2024-05-30 The Surface Start-Up Kit is a tubing set that connects the Thermogard XP® console to a STx™ Vest or Thermogard™ Vest surfac
• 00849111076128 - Thermogard™ Vest, S/M: 2024-05-30 Thermogard™ Vest, S/M
• 00849111076135 - Thermogard™ Vest, L/XL: 2024-05-30 Thermogard™ Vest, L/XL
• 00849111075787 - Thermogard XP, Lang set C, Rohs: 2023-12-18 The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controlle