DEVICE: STAT-PADZ (00847946021184)

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Device Record History
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Device Identifier (DI) Information
STAT-PADZ
8900-000410-01
In Commercial Distribution

Zoll Medical Corporation
00847946021184
GS1

1
055363428 *Terms of Use
STAT-PADZ ADULT/CHILD ELECTRODE, SINGLE
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Device Characteristics
Labeling does not contain MRI Safety Information
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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?
48048 Rechargeable professional automated external defibrillator
A portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it audibly/visually instructs an operator to enable it to activate defibrillation of the heart through application of electrical shocks to the chest surface. The device is intended to be operated by healthcare professionals (e.g., paramedics, medical staff) in healthcare settings. It consists of an external pulse generator (EPG) and a pair of skin-adhesive electrodes to monitor the rhythm and deliver the shocks; it also includes internal rechargeable batteries that must be charged when not in use.
Active false
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FDA Product Code

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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

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Storage and Handling
Handling Environment Temperature: exactly 0 Degrees Celsius
Storage Environment Temperature: exactly 0 Degrees Celsius
Storage Environment Atmospheric Pressure: more than 0 KiloPascal
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
5c223735-9df2-458e-9d63-b2837f6a84e6
February 08, 2022
3
August 03, 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
10847946021181 12 00847946021184 In Commercial Distribution
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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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Yes
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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