10.7F PACKAGED ACCUTROL CATHETER

Basic Information

• Brand Name: 10.7F PACKAGED ACCUTROL CATHETER
• Primary DI: 00849111075404
• Version / Model: NA
• Catalog Number: 8700-000824-01
• Company Name: Zoll Circulation, Inc.
• Labeler DUNS: 799455241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-07-01
• Public Version: 4
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: 05d78c94-f128-42b4-8ea4-547dd318b03b

Device Description

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).

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 Conditional
• 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: No

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	00849111075404	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K080908	000

Device Sizes

Type	Value	Unit	Text
Length	65	Centimeter
Catheter Gauge	10.7	French

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius