DEVICE: ZENIX (00812394022823)

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Device Record History
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Device Identifier (DI) Information
ZENIX
9500-000129
In Commercial Distribution

Zoll Medical Corporation
00812394022823
GS1

1
055363428 *Terms of Use
CABLE, MFC, THOR, EC53
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Device Characteristics
MR Unsafe
No
No
No
No
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?
60635 Electrocardiographic electrode connector
A small clip designed to enable an electrical connection between an electrocardiographic electrode and an electrocardiographic lead wire. It is typically made of plastic materials, with a metallic part to provide electrical connection, and can be manually applied to a dedicated area of a disk-like electrode that is placed on the patient’s skin, with a socket at the other end for a plug on the lead. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MKJ Automated external defibrillators (non-wearable)
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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
Storage Environment Temperature: exactly 0 Degrees Celsius
Storage Environment Humidity: exactly 0 Percent (%) Relative Humidity
Handling Environment Temperature: exactly 0 Degrees Celsius
Storage Environment Atmospheric Pressure: more than 0 KiloPascal
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
24045ba1-007e-4c33-8bbe-b25c8b86e09e
June 25, 2025
1
June 17, 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
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
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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