DEVICE: RefStar QwikPatch (10846835008821)
Device Identifier (DI) Information
RefStar QwikPatch
XRPP8Y
In Commercial Distribution
XRPP8Y
Biosense Webster Inc
XRPP8Y
In Commercial Distribution
XRPP8Y
Biosense Webster Inc
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep out of direct sunlight |
Special Storage Condition, Specify: Keep Dry |
Special Storage Condition, Specify: Do not use if package is damaged |
Special Storage Condition, Specify: Do not use if package is opened |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
a50447d1-9b02-43fe-b247-dd1119481b77
June 07, 2022
5
September 13, 2017
June 07, 2022
5
September 13, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)729-9010
RA-BWIUS-Complaints@its.jnj.com
RA-BWIUS-Complaints@its.jnj.com