Lifeforce
GUDID 00815098020010
DEFIBTECH, L.L.C.
Non-rechargeable public semi-automated external defibrillator| Primary Device ID | 00815098020010 |
| NIH Device Record Key | a4e81a03-1907-4815-9119-42d8de5dfd56 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lifeforce |
| Version Model Number | DDU-100C |
| Company DUNS | 128340200 |
| Company Name | DEFIBTECH, L.L.C. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815098020010 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K013896
FDA Product Code
| MKJ | Automated External Defibrillators (Non-Wearable) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-24 |
Devices Manufactured by DEFIBTECH, L.L.C.
Trademark Results [Lifeforce]
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