AccessGUDID - DEVICE: M SERIES BIPHASIC (00847946003685)

GUDID

Device Identifier (DI) Information

Brand Name: M SERIES BIPHASIC
Version or Model: 40010211101103010
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Zoll Medical Corporation

Primary DI Number: 00847946003685
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 055363428 *Terms of Use

Device Description: Defibrillator ,MAIN, BASIC-4, BIPHASIC, SPO2, PACE, RCD, SMR, CDMK, NELLCOR, AC, 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
DPS	ELECTROCARDIOGRAPH
DRO	PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
MKJ	Automated external defibrillators (non-wearable)
LDD	Dc-defibrillator, low-energy, (including paddles)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K990762	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 Temperature: between -20 and 60 Degrees Celsius
Storage Environment Atmospheric Pressure: more than 0 KiloPascal
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 0 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 6.8" x 10.3" x 8.2"

Device Record Status

Public Device Record Key: 46a7f1f2-92d1-47b2-92ca-5504e70a8ae0
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 19, 2014