DEVICE: ONESTEP PEDIATRIC (00847946016197)

Device Identifier (DI) Information

ONESTEP PEDIATRIC
8900-000219-01
Not in Commercial Distribution

Zoll Medical Corporation
00847946016197
GS1
May 06, 2021
1
055363428 *Terms of Use
ONE STEP PEDIATRIC CPR ELECTRODE (1 pair)
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Device Characteristics

Labeling does not contain MRI Safety Information
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?
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
DQA Oximeter
MKJ Automated external defibrillators (non-wearable)
LDD Dc-defibrillator, low-energy, (including paddles)
DRO PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
DRT MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
LIX AID, CARDIOPULMONARY RESUSCITATION
DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
CCK ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
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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: between 0 and 35 Degrees Celsius
Handling Environment Temperature: between 0 and 50 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 9.3" X 8.5" X 1.0"
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Device Record Status

1312c09e-6920-43b3-a39c-855b4d366363
January 08, 2025
4
September 24, 2014
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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
10847946016194 8 00847946016197 2021-05-06 Not in Commercial Distribution CASE
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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