DEVICE: X SERIES (04560233593534)
Device Identifier (DI) Information
X SERIES
610-2441511-36
In Commercial Distribution
Zoll Medical Corporation
610-2441511-36
In Commercial Distribution
Zoll Medical Corporation
MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, VOICE, NIBP, SPO2, SPCO, SPMET, IBP/TEMP CPR EXPANSION PACK AND ETCO2, FREN JAPANESE
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
17882 | Physiologic-monitoring defibrillation system |
An assembly of electrically-powered devices designed to defibrillate the heart that incorporates additional therapeutic and/or monitoring features intended to resuscitate and/or monitor a cardiac patient. It typically includes devices that enable manual and/or automated external defibrillation (a defibrillator) and one or more of the following: electrocardiogram (ECG) monitoring (electrocardiograph), noninvasive cardiac pacing (temporary pacemaker), cardioversion (CV), pulse oximetry (oximeter), invasive and/or noninvasive blood pressure monitoring, and end-tidal carbon dioxide (EtCO2) monitoring (i.e., a CO2 monitor). It may have data recording/printing capabilities.
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FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DRT | MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) |
DQA | Oximeter |
MKJ | Automated external defibrillators (non-wearable) |
CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
DRO | PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) |
DSK | COMPUTER, BLOOD-PRESSURE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K112432 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -30 and 70 Degrees Celsius |
Handling Environment Temperature: between 0 and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure: more than 0 KiloPascal |
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 8.9" x 10.4" x 8.75" |
Device Record Status
6fd72a01-ce2d-4e56-b6ba-71e0bfd1bed5
July 06, 2018
3
June 19, 2015
July 06, 2018
3
June 19, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined