DEVICE: CARDIOTRONIC (04260451441029)

Device Identifier (DI) Information

CARDIOTRONIC
PACE 203
In Commercial Distribution

Osypka Medical GmbH
04260451441029
GS1

1
317157048 *Terms of Use
PACE 203 External Dual-Chamber Pacemaker
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
External pacemaker, epicardial pacing An external pulse generator (EPG) designed to generate periodic electrical cardiac pacing impulses and transmits them to the heart via invasive (percutaneous) leads to stimulate the heart when the sino-atrial (SA) node is not functioning properly or when the heart has a conductive disorder. It is commonly used: 1) in an emergency; 2) during surgery; or 3) following open-heart surgery until the heart recovers. It is not intended for defibrillation or cardioversion. The leads (not included) are inserted into the heart through a major vein (e.g., subclavian) or attached directly to the heart wall.
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FDA Product Code

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Product Code Product Code Name
DTE Pulse-Generator, Pacemaker, External
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K020896 000
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between -20 and 60 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

ed2e306e-b395-4730-a4ae-203d24a64a22
October 05, 2018
4
September 13, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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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

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No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1 858 454 0600
mail@cardiotronic.net
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