RefStar QwikPatch

Basic Information

• Brand Name: RefStar QwikPatch
• Primary DI: 10846835008821
• Version / Model: XRPP8Y
• Catalog Number: XRPP8Y
• Company Name: Biosense Webster Inc
• Labeler DUNS: 020163218
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-13
• Public Version: 5
• Public Version Date: 2022-06-07
• Public Version Status: Update
• Public Device Record Key: a50447d1-9b02-43fe-b247-dd1119481b77

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: Labeling does not contain MRI Safety Information
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRF	CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING	Cardiovascular	870.1220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46007	Cardiac mapping system reference patch	A component of a cardiac mapping system that is an adhesive device placed on the surface of a patient's body, typically the chest and/or back, to provide a fixed reference point for the tip of an internal, non-fluoroscopic catheter during an electrophysiological and electromechanical real-time mapping of the heart. It may be sensor-containing or have a sensor attached to it, and is used to compensate for patient movement during the procedure. It is typically used with a cardiac mapping system computer to assist in the location and navigation of the catheter tip, and to provide electrocardiogram information. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10846835008821	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep out of direct sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry
• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if package is damaged
• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if package is opened