CATHETER INTRODUCER KIT, 10.7F 8700-000829-01

GUDID 00849111075435

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 10.7 Fr diameter.

Zoll Circulation, Inc.

Intravascular heating/cooling system catheter

• Primary Device ID: 00849111075435
• NIH Device Record Key: 2fe7644a-7a0b-453b-aa89-1bac2b7e5f09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CATHETER INTRODUCER KIT, 10.7F
• Version Model Number: NA
• Catalog Number: 8700-000829-01
• Company DUNS: 799455241
• Company Name: Zoll Circulation, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 10.7 French
• Catheter Gauge: 10.7 French
• Catheter Gauge: 10.7 French
• Catheter Gauge: 10.7 French
• Catheter Gauge: 10.7 French
• Catheter Gauge: 10.7 French
• Catheter Gauge: 10.7 French
• Catheter Gauge: 10.7 French
• Catheter Gauge: 10.7 French
• Catheter Gauge: 10.7 French
• Catheter Gauge: 10.7 French
• Catheter Gauge: 10.7 French
• Catheter Gauge: 10.7 French
• Catheter Gauge: 10.7 French
• Catheter Gauge: 10.7 French
• Catheter Gauge: 10.7 French
• Catheter Gauge: 10.7 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849111075435 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-07-01

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• 00849111075794 - Thermogard XP, Lang set C, Rohs, Refurb: 2023-12-18 The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controlle
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