DEVICE: 5391 (00643169382978)

Device Identifier (DI) Information

5391
5391
Not in Commercial Distribution
5391
Oscor Inc.
00643169382978
GS1
April 13, 2017
1
101835833 *Terms of Use
Single Chamber External Pacemaker
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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?
35224 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DTE PULSE-GENERATOR, PACEMAKER, EXTERNAL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K033130 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 5 and 30 Degrees Celsius
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Clinically Relevant Size

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

f6f3a52f-f7ee-4575-bdd4-d943ce496f04
September 10, 2021
5
September 09, 2016
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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(727)937-2511
sales@oscor.com
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