Start-Up Kit Custom Luer

Basic Information

• Brand Name: Start-Up Kit Custom Luer
• Primary DI: 00849111075336
• Version / Model: CG-500D
• Catalog Number: 8700-0784-01
• Company Name: Zoll Circulation, Inc.
• Labeler DUNS: 799455241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-07-15
• Public Version: 4
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: 58772cc1-6e91-4910-8848-14a1b691511f

Device Description

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

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: 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
46315	Intravascular core temperature regulation system start kit	A collection of devices intended to be used to facilitate the function of intravascular core temperature regulation system. It typically includes tubing to connect the pump mechanism of the control unit, a heat exchange coil, a spike for insertion into the bag of fluid used in the system (e.g., normal saline), an air trap, a flow indicator, and a Luer-lock connection for the intravascular catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00849111075336	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K014241	000

Device Sizes

Type	Value	Unit	Text
Length	6	Feet

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 40 Degrees Celsius