TRACOE® twist
GUDID 04035324027866
Spare Inner Cannulas, with 15 mm Connector, 30 units
Tracoe medical GmbH
Tracheostomy tube, non-reinforced, non-customized, single-use| Primary Device ID | 04035324027866 |
| NIH Device Record Key | d8f88ad6-bb8d-4532-a947-c36cbe27cdf7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRACOE® twist |
| Version Model Number | REF 501-08-XXX |
| Company DUNS | 319414785 |
| Company Name | Tracoe medical GmbH |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com | |
| Phone | +49613691690 |
| info@tracoe.com |
Device Dimensions
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage forless or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04035324027866 [Primary] |
| GS1 | 05701780327961 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K961449
FDA Product Code
| JOH | Tube tracheostomy and tube cuff |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-23 |
| Device Publish Date | 2023-06-15 |
On-Brand Devices [TRACOE® twist]
| 04035324027972 | Spare Inner Cannulas, with 15 mm Connector, 30 units |
| 04035324027965 | Spare Inner Cannulas, with 15 mm Connector, 30 units |
| 04035324027958 | Spare Inner Cannulas, with 15 mm Connector, 30 units |
| 04035324027866 | Spare Inner Cannulas, with 15 mm Connector, 30 units |
Trademark Results [TRACOE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRACOE 75072311 2117376 Live/Registered |
TRACOE MEDICAL GMBH 1996-03-12 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.