DEVICE: RefStar QwikPatch (10846835008821)

Device Identifier (DI) Information

RefStar QwikPatch
XRPP8Y
In Commercial Distribution
XRPP8Y
Biosense Webster Inc
10846835008821
GS1

1
020163218 *Terms of Use
No description.
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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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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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
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

a50447d1-9b02-43fe-b247-dd1119481b77
June 07, 2022
5
September 13, 2017
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)729-9010
RA-BWIUS-Complaints@its.jnj.com
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