DDU-100 Lifeline AED with RX form and cabinet - DDU-100 Lifeline AED, US, English, 1 set Adult - DEFIBTECH, L.L.C.

Duns Number:128340200

Device Description: DDU-100 Lifeline AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501), DDU-100 Lifeline 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), alarmed wall mount cabinet (DAC-220), rescue pack (DAC-420), 3-way wall sign (DAC-230), prescription activation form

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

DDU-100 Lifeline AED with RX form and cabinet

Version/Model Number

CCPRX-0001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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"

-

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 Details

Product Code

MKJ

Product Code Name

Automated External Defibrillators (Non-Wearable)

Device Record Status

Public Device Record Key

b8ed60d7-96bf-4ad1-ad83-86eee5ed4b73

Public Version Date

August 09, 2021

Public Version Number

1

DI Record Publish Date

July 30, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DEFIBTECH, L.L.C." Characteristics
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