Cool Line® Intravascular Heat Exchange Catheter Kit Japan, Final Pkged Kit Ne

Basic Information

• Brand Name: Cool Line® Intravascular Heat Exchange Catheter Kit Japan, Final Pkged Kit Ne
• Primary DI: 00849111075176
• Version / Model: CL-2295
• Company Name: Zoll Circulation, Inc.
• Labeler DUNS: 799455241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-10
• Public Version: 4
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: eb493b66-dd4f-41d5-a3c1-22d9c93af11a

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NCX	System, Hypothermia, Intravenous, Cooling	Cardiovascular	870.5900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44708	Intravascular core temperature regulation system catheter	A flexible tube with an attached membrane (e.g., a balloon) intended to be inserted into the central venous system (CVS) to circulate through the membrane a temperature-controlled fluid (e.g., saline solution), in order to both heat and alternatively cool a patient's blood through the transfer of heat across the membrane. It may have built-in sensors to monitor the patient's body temperature for feedback to a connected control unit. It may be used for body temperature regulation during surgery, intensive care, or for fever management. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00849111075176	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K101987	000

Device Sizes

Type	Value	Unit	Text
Length	22	Centimeter
Catheter Gauge	9.3	French