Primary Device ID | 09351567000035 |
NIH Device Record Key | b5791608-232f-46c4-8496-f802f092f1ae |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | O2Vent Optima |
Version Model Number | O2Vent Optima |
Company DUNS | 748034696 |
Company Name | OVENTUS MANUFACTURING PTY LTD |
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 | true |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 09351567000035 [Primary] |
LRK | Device, Anti-Snoring |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-01-13 |
Device Publish Date | 2020-01-03 |
09351567000035 | The O2Vent Optima is a removable medical device that is fitted in the patient’s mouth and is i |
09351567000363 | The O2Vent OptimaMini is a removable medical device that is fitted in the patient’s mouth and |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
O2VENT OPTIMA 79250334 not registered Live/Pending |
Oventus Medical Limited 2018-12-19 |