Duns Number:128340200
Device Description: DDU-120 Lifeline AUTO AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC- DDU-120 Lifeline AUTO AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501), Op. Guide (DAC-A581-EN), 5 year battery pack with 9V Lithium battery (DCF-200), prescription activation form
Catalog Number
-
Brand Name
DDU-120 Lifeline AED with RX activation form
Version/Model Number
DCF-A120RX-EN
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MKJ
Product Code Name
Automated External Defibrillators (Non-Wearable)
Public Device Record Key
89b9b717-2e7d-460d-83d0-df9d5efdad69
Public Version Date
August 09, 2021
Public Version Number
1
DI Record Publish Date
July 30, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |
| 3 | A medical device with high risk that requires premarket approval | 68 |