AccessGUDID - DEVICE: X SERIES (00847946019938)

GUDID

Device Identifier (DI) Information

Brand Name: X SERIES
Version or Model: 620-0211010-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Zoll Medical Corporation

Primary DI Number: 00847946019938
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 055363428 *Terms of Use

Device Description: Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 3/5 LEAD, NELLCOR, PACING, NIBP, SPO2, EXPANSION PACK AND ETCO2, DMST

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
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
DRT	MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112432	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -30 and 70 Degrees Celsius
Storage Environment Atmospheric Pressure: more than 0 KiloPascal
Handling Environment Temperature: between 0 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 8.9" x 10.4" x 8.75"

Device Record Status

Public Device Record Key: d08e5d18-f792-48ee-beb5-0de8f0c00489
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 06, 2017