| Primary Device ID | 00643169719972 |
| NIH Device Record Key | 1f47b49c-3460-4960-b633-b3b254d8b217 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | S0278-00 |
| Company DUNS | 835465063 |
| Company Name | MEDTRONIC XOMED, 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 00643169719972 [Primary] |
| LXB | Hearing aid, bone conduction |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-10-22 |
| Device Publish Date | 2017-10-02 |
| 00763000309480 - Causse/Polycel | 2025-07-01 PROSTHESIS 1156376 CAUSSE FLPL PARTIAL |
| 20763000870359 - Microgel | 2025-07-01 VENT TUBE 1082201 5PK PAPA TYPE 1.14 |
| 20763000870366 - Sheehy | 2025-07-01 VENT TUBE 1083301 5PK SHEEHY TYPE 1.27 |
| 20763000870373 - 20763000870373 | 2025-07-01 VENT TUBE 1084401 5PK GROMMET 1.27 |
| 20763000870380 - Reuter | 2025-07-01 VENT TUBE 1010201 5PK BOBBIN 1.14 FLPL |
| 20763000870403 - Sheehy | 2025-07-01 VENT TUBE 1013301 5PK BUTTON 1.27 FLPL |
| 20763000870410 - Donaldson | 2025-07-01 VENT TUBE 1015101 5PK DONLDSN 1.14 FLPL |
| 20763000870427 - Shepard | 2025-07-01 VENT TUBE 1016101 5PK GROMMET 1.14 FLPL |