FDA UDI In Commercial Distribution 🇺🇸 United States

DDU-120 Lifeline AED with RX activation form

DI: 00815098020751 · Model: DCF-A120RX-EN · DEFIBTECH, L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
DDU-120 Lifeline AED with RX activation form
Primary DI
00815098020751
Version / Model
DCF-A120RX-EN
Company Name
DEFIBTECH, L.L.C.
Labeler DUNS
128340200
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-07-30
Public Version
1
Public Version Date
2021-08-09
Public Version Status
New
Public Device Record Key
89b9b717-2e7d-460d-83d0-df9d5efdad69

Device Description

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

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
No
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
48047 Non-rechargeable public automated external defibrillator

Identifiers

Type ID
Primary 00815098020751