ReviveR Pro
GUDID 00815098020263
DEFIBTECH, L.L.C.
Non-rechargeable professional semi-automated external defibrillator| Primary Device ID | 00815098020263 |
| NIH Device Record Key | 531dd7ee-2b47-4d0d-abf1-ad1e74d7c24b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ReviveR Pro |
| Version Model Number | DDU-C2400 |
| 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 | 00815098020263 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121853
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 [ReviveR Pro]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REVIVER PRO 85850069 4637814 Live/Registered |
Cintas Holdings LLC 2013-02-14 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.