DEVICE: CareLink SmartSync™ (00643169868540)

Device Identifier (DI) Information

CareLink SmartSync™
24970A
In Commercial Distribution

MEDTRONIC, INC.
00643169868540
GS1

1
006261481 *Terms of Use
PROGRAMMER 24970A USA
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Implantable pacemaker analyser, intraoperative An electronic instrument designed to test an implanted cardiac pacemaker, including the lead/tissue interface at the time of implantation, for invasive pacemaker evaluation and/or during electrophysiology (EP) diagnostic procedures. It has testing and recording capabilities to measure the minimum electrical stimulus needed to elicit ventricular contraction and the minimum intracardiac signal amplitude needed to inhibit the pacemaker (i.e., stimulation and sensing thresholds respectively). It typically includes measuring devices for the bioelectrical signals, a pulse generator, controllers, and the capability to test the characteristics and performance of the implanted pacemaker.
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FDA Product Code

[?]
Product Code Product Code Name
DTC ANALYZER, PACEMAKER GENERATOR FUNCTION
DTA TESTER, PACEMAKER ELECTRODE FUNCTION
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K163008 000
P890003 406
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Humidity: between 15 and 93 Percent (%) Relative Humidity
Handling Environment Temperature: between -30 and 55 Degrees Celsius
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Clinically Relevant Size

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

5e1d0bdf-ab88-4fc6-8900-f0a8813a86af
July 02, 2019
4
May 25, 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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

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