ReviveR Auto
GUDID 00815098020065
DEFIBTECH, L.L.C.
Non-rechargeable public automated external defibrillator| Primary Device ID | 00815098020065 |
| NIH Device Record Key | 08bce080-e4ed-4055-bfb6-f2fc6ef62eaa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ReviveR Auto |
| Version Model Number | DDU-120B |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815098020065 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K113787
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 Auto]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REVIVER AUTO 87550358 not registered Dead/Abandoned |
REVIVERMX, Inc. 2017-07-31 |
 REVIVER AUTO 85850061 4503051 Live/Registered |
Cintas Holdings LLC 2013-02-14 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.