AccessGUDID - DEVICE: R SERIES (00847946042158)

GUDID

Device Identifier (DI) Information

Brand Name: R SERIES
Version or Model: 30320009001330012
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Zoll Medical Corporation

Primary DI Number: 00847946042158
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 055363428 *Terms of Use

Device Description: R SERIES, ALS, 3/5 LD, STD ECG, AC PWR, PACE, SPO2/NIBP, CF/STD, 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?
37806	Manual external defibrillator	An external pulse generator (EPG) designed to deliver electrical shocks to defibrillate the heart (restore normal rhythm) in a procedure initiated by a healthcare professional operator who monitors an electrocardiogram (ECG) to determine when to treat life-threatening arrhythmias (ventricular fibrillation and pulseless ventricular tachycardia) in sudden cardiac arrest (SCA) patients. The device typically includes external electrodes (e.g., skin-adhesive or hand-held paddle-type) or internal electrodes (e.g., near open heart), and may have a synchronizing capability; it also includes internal rechargeable batteries that must be charged when not in use. It is widely used in medical facilities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MKJ	Automated external defibrillators (non-wearable)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 Atmospheric Pressure: more than 0 KiloPascal
Storage Environment Temperature: exactly 0 Degrees Celsius
Storage Environment Humidity: exactly 0 Percent (%) Relative Humidity
Handling Environment Temperature: exactly 0 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9a329640-64c3-49f3-a2b0-35ae3dab2a0e
Public Version Date: March 25, 2024
Public Version Number: 1
DI Record Publish Date: March 16, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES