FDA UDI
In Commercial Distribution
🇺🇸 United States
DDU-100 Lifeline AED with RX form and cabinet
DI: 00815098020805
·
Model: CCPRX-0003
·
DEFIBTECH, L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DDU-100 Lifeline AED with RX form and cabinet
- Primary DI
- 00815098020805
- Version / Model
- CCPRX-0003
- 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
- 6d6bd6b9-b481-4b65-9d70-e954683ae178
Device Description
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), soft carry case (DAC-100), pediatric pads (DDP-200P), 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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | Cardiovascular | 870.5310 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47910 | Non-rechargeable public semi-automated external defibrillator | A portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it audibly/visually instructs an operator to enable it to activate defibrillation of the heart through application of electrical shocks to the chest surface. It is placed in conspicuous public locations and is intended to be operated by a layperson. It consists of two skin-adhesive, cartridge-type, disposable electrodes containing non-rechargeable batteries that provide the shock energy, and an electrode-regulating external pulse generator (EPG), which may include a CPR feedback. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815098020805 | GS1 |