DEVICE: Paddle (00847946023027)

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Device Identifier (DI) Information
Paddle
8000-1020
In Commercial Distribution

Zoll Medical Corporation
00847946023027
GS1

1
055363428 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
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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?
44770 External defibrillation electrode, paediatric, reusable
An electrical conductor intended to be used in pairs to transmit a controlled electrical shock from an external defibrillator to a pre-pubescent patient in order to defibrillate the heart (restore a normal rhythm) or slow a rapid heart rate. It usually consists of a cable set that terminates with electrodes (paddles) that are hand-held by the operator to the chest (the intact torso) or back of the patient so that the discharge passes across the region of the heart. Typically available as a set of two electrodes with a combined cable/connector, or as a single electrode with cable/connector, in which case two will be connected to the external pulse generator (EPG). This is a reusable device.
Active false
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FDA Product Code

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Product Code Product Code Name
LDD Dc-defibrillator, low-energy, (including paddles)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K062537 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 Atmospheric Pressure: more than 0 KiloPascal
Handling Environment Temperature: exactly 0 Degrees Celsius
Storage Environment Temperature: exactly 0 Degrees Celsius
Storage Environment Humidity: exactly 0 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
eddb37c5-5c62-47d1-95ca-82b32fd81f2c
July 06, 2023
4
October 21, 2015
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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)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
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No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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