AccessGUDID - DEVICE: R SERIES (04560233593121)

GUDID

Device Identifier (DI) Information

Brand Name: R SERIES
Version or Model: 30001005201310362
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Zoll Medical Corporation

Primary DI Number: 04560233593121
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 055363428 *Terms of Use

Device Description: Defibrillator ,MAIN,ALS,MAN-1,3/5 LD,STD ECG,AC PWR,SPO2,ETCO2,PACE,NIBP,CF/USB,R SERIES, JAPAN

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?
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

FDA Product Code

[?]

Product Code	Product Code Name
DRO	PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
DPS	ELECTROCARDIOGRAPH
LLD	PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAPERITONEAL
MKJ	Automated external defibrillators (non-wearable)

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
Handling Environment Temperature: between 0 and 55 Degrees Celsius
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity

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: b66b5545-accc-4902-abb8-26616a99b253
Public Version Date: December 31, 2019
Public Version Number: 4
DI Record Publish Date: October 23, 2015