FDA UDI In Commercial Distribution 🇺🇸 United States

AED Manager, V.2.2.1.1 Powerheart G5

DI: 00812394021505 · Model: 40-00296-05 · Zoll Medical Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
AED Manager, V.2.2.1.1 Powerheart G5
Primary DI
00812394021505
Version / Model
40-00296-05
Catalog Number
40-00296-05
Company Name
Zoll Medical Corporation
Labeler DUNS
055363428
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-05-28
Public Version
3
Public Version Date
2022-11-14
Public Version Status
Update
Public Device Record Key
07a2582d-34c2-4ed6-9470-76840e05e3b7

Device Description

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

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
MKJ Automated External Defibrillators (Non-Wearable)

GMDN Terms

Code Name
41581 External defibrillator application software

Identifiers

Type ID
Primary 00812394021505

Customer Contacts