DEVICE: N/A (00763000954369)

Device Identifier (DI) Information

N/A
AFR-00007
In Commercial Distribution

MEDTRONIC, INC.
00763000954369
GS1

1
006261481 *Terms of Use
PATCH AFR-00007 LOCATION REF 4PK US
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
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
OAE Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
OAD catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
DQK Computer, diagnostic, programmable
QZI Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K233943 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep dry
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Clinically Relevant Size

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

6a019256-bb2a-46c3-9d5a-f71a47d6cbd6
March 03, 2025
1
February 22, 2025
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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
20763000954363 4 00763000954369 In Commercial Distribution PK
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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
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
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