AccessGUDID - DEVICE: AED Manager, V.2.2.1.1 Powerheart G5 (00812394021505)

GUDID

Device Identifier (DI) Information

Brand Name: AED Manager, V.2.2.1.1 Powerheart G5
Version or Model: 40-00296-05
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 40-00296-05
Company Name: Zoll Medical Corporation

Primary DI Number: 00812394021505
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 055363428 *Terms of Use

Device Description: Event Reporting and Administrative AED Configuration Software V.2.2.1.1 for Powerheart G5

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?
41581	External defibrillator application software	An individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to a defibrillator intended for external use on the thorax so that it may function according to its intended purpose. A basic set of applications programs and routines are included with the defibrillator and can be upgraded to correct programming errors or to add new system capabilities. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 07a2582d-34c2-4ed6-9470-76840e05e3b7
Public Version Date: November 14, 2022
Public Version Number: 3
DI Record Publish Date: May 28, 2020