TRACOE® comfort
GUDID 04035324032204
Additional Extra-Long Inner Cannula, Fenestrated, with Speaking Valve, with additional oxygen supply port
Tracoe medical GmbH
Basic tracheostomy tube, single-use| Primary Device ID | 04035324032204 |
| NIH Device Record Key | 4c381b61-11dc-45e0-acba-36b7f0614615 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRACOE® comfort |
| Version Model Number | REF 888-204-08IK-O |
| 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 | true |
| 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 |
Device Dimensions
| Lumen/Inner Diameter | 6.7 Millimeter |
| Lumen/Inner Diameter | 6.7 Millimeter |
| Lumen/Inner Diameter | 6.7 Millimeter |
| Lumen/Inner Diameter | 6.7 Millimeter |
| Lumen/Inner Diameter | 6.7 Millimeter |
| Lumen/Inner Diameter | 6.7 Millimeter |
| Lumen/Inner Diameter | 6.7 Millimeter |
| Lumen/Inner Diameter | 6.7 Millimeter |
| Lumen/Inner Diameter | 6.7 Millimeter |
| Lumen/Inner Diameter | 6.7 Millimeter |
| Lumen/Inner Diameter | 6.7 Millimeter |
| Lumen/Inner Diameter | 6.7 Millimeter |
| Lumen/Inner Diameter | 6.7 Millimeter |
| Lumen/Inner Diameter | 6.7 Millimeter |
| Lumen/Inner Diameter | 6.7 Millimeter |
| Lumen/Inner Diameter | 6.7 Millimeter |
| Lumen/Inner Diameter | 6.7 Millimeter |
| Lumen/Inner Diameter | 6.7 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Products must be stored in cool and dry location. Temporary storage for less 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 for less 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 for less 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 for less 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 for less 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 for less 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 for less 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 for less 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 for less 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 for less 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 for less 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 for less 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 for less 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 for less 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 for less 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 for less 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 for less 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 for less or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04035324032204 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K781729
FDA Product Code
| BTO | Tube, tracheostomy (w/wo connector) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-10 |
| Device Publish Date | 2020-04-02 |
On-Brand Devices [TRACOE® comfort]
| 04035324031856 | Inner Cannula (substitute), extra long with speaking Valve, clamp below, variant |
| 04035324032204 | Additional Extra-Long Inner Cannula, Fenestrated, with Speaking Valve, with additional oxygen su |
| 04035324032198 | Extra-Long Tube, with 2 Inner cannula with 15 mm Connector, one Fenestrated and with clamp abov |
| 04035324032235 | Extra-Long spare inner tube, Fenestrated, with speaking valve variation |
| 04035324032259 | Spare-tube, with 22 mm adapter |
| 04035324032273 | Spare inner tube, with speaking valve type A (silver valve holder), with oxygen supply port |
| 04035324032242 | Spare inner tube, with speaking valve type A (silver valve holder), hook below |
| 04035324032280 | Spare inner tube, with speaking valve type B, hook above |
| 04035324032266 | comfort variant, spare inner tube with speaking valve type B |
| 04035324032303 | comfort variant, spare inner tube with speaking valve type B, hook top |
| 04035324031764 | Spare-tube, with 22 mm adapter, with clamp below |
| 04035324031733 | Spare inner tube, with Swivel Speaking Valve, Type B, clamp below |
| 04035324031726 | Spare inner tube, with Swivel Speaking Valve, Type B |
| 04035324028672 | Extra-Long spare inner tube, Fenestrated, with speaking valve variation |
Trademark Results [TRACOE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRACOE 75072311 2117376 Live/Registered |
TRACOE MEDICAL GMBH 1996-03-12 |
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