| Primary Device ID | 10859290006462 |
| NIH Device Record Key | 514078d3-982e-45eb-af5f-62b1a8bd3539 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Truer Bougie Coiled |
| Version Model Number | 90553 |
| Company DUNS | 003530786 |
| Company Name | TRUER MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| 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 | 00859290006465 [Primary] |
| GS1 | 10859290006462 [Package] Contains: 00859290006465 Package: Box [10 Units] In Commercial Distribution |
| KCD | Bougie, Esophageal, Ent |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-02 |
| Device Publish Date | 2023-09-22 |
| 10859290006486 - Sharn by Marketlab | 2024-11-06 The Sharn by Marketlab Skin Temperature Sensor is designed for monitoring a patient’s skin surface temperature during surgical |
| 00859290006472 - HP to 3.5mm Phonojack Cable with Shrinkwrap | 2024-01-24 HP to 3.5mm Phonojack Cable with Shrinkwrap |
| 10859290006462 - Truer Bougie Coiled | 2023-10-02Truer Medical’s new Bougie is a latex-free, calibrated introducer designed to ensure accurate distance insertion. |
| 10859290006462 - Truer Bougie Coiled | 2023-10-02 Truer Medical’s new Bougie is a latex-free, calibrated introducer designed to ensure accurate distance insertion. |
| 00859290006441 - 400 Series Right Angle Cable (80 cm) | 2023-07-27 Truer Medical Temperature Monitoring Interface Cables offer several different interface configurations. By standardizing tempera |
| 00859290006458 - 400 Series Right Angle Cable (160 cm) | 2023-07-27 Truer Medical Temperature Monitoring Interface Cables offer several different interface configurations. By standardizing tempera |
| 10859290006417 - Nasal Cannula | 2022-09-16 Adult Nasal Cannula w/7' safety channel tubing |
| 00859290006236 - Truer Bougie | 2022-09-06 Truer Medical’s new Bougie is a latex free, calibrated introducer designed to ensure accurate distance insertion. Truer Medica |
| 00859290006366 - HP 400 series type monitor cable | 2022-07-14 Truer Medical Temperature Monitoring Interface Cables offer several different interface configurations. By standardizing tempera |