| Primary Device ID | 00853386007046 |
| NIH Device Record Key | dee070fa-ff46-4306-b33a-5894d180d061 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hummingbird Tympanostomy Tube System |
| Version Model Number | 05-1001-503 |
| Company DUNS | 011948777 |
| Company Name | PRECEPTIS MEDICAL, INC |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | 00853386007039 [Primary] |
| GS1 | 00853386007046 [Package] Contains: 00853386007039 Package: Box [5 Units] In Commercial Distribution |
| ETD | Tube, Tympanostomy |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-08-31 |
| 00853386007046 | 05-1001-503, -90/-90 Inserter Assembly With Pre-loaded Vent Tube |
| 00853386007053 | 05-1001-502, +90/+90 Inserter Assembly With Pre-loaded Vent Tube |
| 00853386007015 | 05-1001-501, +90/-90 Inserter Assembly With Pre-loaded Vent Tube |
| 50853386007072 | 05-1001-653, +90 Inserter With Pre-loaded Vent Tube |
| 50853386007065 | 05-1001-652, -90 Inserter With Pre-loaded Vent Tube |