| Primary Device ID | 00859290006236 |
| NIH Device Record Key | 5811532c-f88d-4f43-8210-5a2b1e4fd657 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Truer Bougie |
| Version Model Number | 90552 |
| 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 | 00859290006236 [Primary] |
| GS1 | 10859290006233 [Package] Package: carton [10 Units] In Commercial Distribution |
| GS1 | 30859290006237 [Package] Contains: 10859290006233 Package: carton [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 | 2022-09-06 |
| Device Publish Date | 2022-08-29 |
| 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 | 2023-10-02 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 | 2022-09-06Truer Medical’s new Bougie is a latex free, calibrated introducer designed to ensure accurate distance insertion. Truer Medical’s Bougie is the most adaptable, cost effective bougie available in the market. Low density polyethylene frosted finish sheath reduces friction and provides proper stiffness for ease of insertion. Multiple depth marks and malleable for straight or coudé tip. |
| 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 |