TRACOE® vario
GUDID 04035324027736
TRACOE vario Tracheostomy Tube with Adjustable Neck Flange, fenestrated
Tracoe medical GmbH
Tracheostomy tube, non-reinforced, non-customized, single-use| Primary Device ID | 04035324027736 |
| NIH Device Record Key | a51de143-688d-4e7e-8423-6f92f90ae526 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRACOE® vario |
| Version Model Number | REF 464-07 |
| Company DUNS | 319414785 |
| Company Name | Tracoe medical GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 |
Device Dimensions
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
| Lumen/Inner Diameter | 7 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place, Protect from sunlight, Storage temperature limits: 10-40°C |
| 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 | 04035324027736 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K203362
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 | 2021-08-27 |
| Device Publish Date | 2021-08-19 |
On-Brand Devices [TRACOE® vario]
| 04035324017065 | TRACOE vario XL Tracheostomy Tube, Extra-Long, Spiral-Reinforced, with Adjustable Neck Flange an |
| 04035324017058 | TRACOE vario XL Tracheostomy Tube, Extra-Long, Spiral-Reinforced, with Adjustable Neck Flange an |
| 04035324017041 | TRACOE vario XL Tracheostomy Tube, Extra-Long, Spiral-Reinforced, with Adjustable Neck Flange an |
| 04035324017034 | TRACOE vario Tracheostomy Tube Spiral-Reinforced, with Adjustable Neck Flange and Low Pressure C |
| 04035324017027 | TRACOE vario Tracheostomy Tube Spiral-Reinforced, with Adjustable Neck Flange and Low Pressure C |
| 04035324017003 | TRACOE vario Tracheostomy Tube Spiral-Reinforced, with Adjustable Neck Flange and Low Pressure C |
| 04035324015290 | TRACOE vario XL Tracheostomy Tube, Extra-Long, Spiral-Reinforced, with Adjustable Neck Flange an |
| 04035324015283 | TRACOE vario XL Tracheostomy Tube, Extra-Long, Spiral-Reinforced, with Adjustable Neck Flange an |
| 04035324015276 | TRACOE vario XL Tracheostomy Tube, Extra-Long, Spiral-Reinforced, with Adjustable Neck Flange an |
| 04035324015269 | TRACOE vario XL Tracheostomy Tube, Extra-Long, Spiral-Reinforced, with Adjustable Neck Flange an |
| 04035324012398 | TRACOE vario Tracheostomy Tube Spiral-Reinforced, with Adjustable Neck Flange |
| 04035324012381 | TRACOE vario Tracheostomy Tube Spiral-Reinforced, with Adjustable Neck Flange |
| 04035324012374 | TRACOE vario Tracheostomy Tube Spiral-Reinforced, with Adjustable Neck Flange |
| 04035324012367 | TRACOE vario Tracheostomy Tube Spiral-Reinforced, with Adjustable Neck Flange |
| 04035324012350 | TRACOE vario Tracheostomy Tube Spiral-Reinforced, with Adjustable Neck Flange |
| 04035324012343 | TRACOE vario Tracheostomy Tube Spiral-Reinforced, with Adjustable Neck Flange |
| 04035324012336 | TRACOE vario Tracheostomy Tube Spiral-Reinforced, with Adjustable Neck Flange and Low Pressure C |
| 04035324012329 | TRACOE vario Tracheostomy Tube Spiral-Reinforced, with Adjustable Neck Flange and Low Pressure C |
| 04035324012305 | TRACOE vario Tracheostomy Tube Spiral-Reinforced, with Adjustable Neck Flange and Low Pressure C |
| 04035324012299 | TRACOE vario Tracheostomy Tube Spiral-Reinforced, with Adjustable Neck Flange and Low Pressure C |
| 04035324012282 | TRACOE vario Tracheostomy Tube Spiral-Reinforced, with Adjustable Neck Flange and Low Pressure C |
| 04035324012275 | TRACOE vario Tracheostomy Tube Spiral-Reinforced, with Adjustable Neck Flange and Low Pressure C |
| 04035324019052 | TRACOE vario XL Tracheostomy Tube, Extra-Long, with Adjustable Neck Flange and Low Pressure Cuff |
| 04035324019045 | TRACOE vario XL Tracheostomy Tube, Extra-Long, with Adjustable Neck Flange and Low Pressure Cuff |
| 04035324019038 | TRACOE vario XL Tracheostomy Tube, Extra-Long, with Adjustable Neck Flange and Low Pressure Cuff |
| 04035324019021 | TRACOE vario XL Tracheostomy Tube, Extra-Long, with Adjustable Neck Flange and Low Pressure Cuff |
| 04035324019007 | TRACOE vario XL Tracheostomy Tube, Extra-Long, with Adjustable Neck Flange and Low Pressure Cuff |
| 04035324018994 | TRACOE vario XL Tracheostomy Tube, Extra-Long, with Adjustable Neck Flange and Low Pressure Cuff |
| 04035324018987 | TRACOE vario XL Tracheostomy Tube, Extra-Long, with Adjustable Neck Flange and Low Pressure Cuff |
| 04035324018970 | TRACOE vario XL Tracheostomy Tube, Extra-Long, with Adjustable Neck Flange and Low Pressure Cuff |
| 04035324017805 | TRACOE vario Tracheostomy Tube with Adjustable Neck Flange and Low Pressure Cuff, with minimally |
| 04035324017799 | TRACOE vario Tracheostomy Tube with Adjustable Neck Flange and Low Pressure Cuff with minimally |
| 04035324017782 | TRACOE vario Tracheostomy Tube with Adjustable Neck Flange and Low Pressure Cuff, with minimally |
| 04035324017096 | TRACOE vario extra Tracheostomy Tube with Adjustable Neck Flange, Low Pressure Cuff and Subglott |
| 04035324017089 | TRACOE vario extra Tracheostomy Tube with Adjustable Neck Flange, Low Pressure Cuff and Subglott |
| 04035324013043 | TRACOE vario extra Tracheostomy Tube with Adjustable Neck Flange, Low Pressure Cuff and Subglott |
| 04035324013036 | TRACOE vario extra Tracheostomy Tube with Adjustable Neck Flange, Low Pressure Cuff and Subglott |
| 04035324013029 | TRACOE vario extra Tracheostomy Tube with Adjustable Neck Flange, Low Pressure Cuff and Subglott |
| 04035324013005 | TRACOE vario extra Tracheostomy Tube with Adjustable Neck Flange, Low Pressure Cuff and Subglott |
| 04035324012466 | TRACOE vario Tracheostomy Tube with Adjustable Neck Flange and Low Pressure Cuff |
| 04035324012459 | TRACOE vario Tracheostomy Tube with Adjustable Neck Flange and Low Pressure Cuff |
| 04035324012442 | TRACOE vario Tracheostomy Tube with Adjustable Neck Flange and Low Pressure Cuff |
| 04035324012435 | TRACOE vario Tracheostomy Tube with Adjustable Neck Flange and Low Pressure Cuff |
| 04035324012428 | TRACOE vario Tracheostomy Tube with Adjustable Neck Flange and Low Pressure Cuff |
| 04035324012404 | TRACOE vario Tracheostomy Tube with Adjustable Neck Flange and Low Pressure Cuff |
| 04035324027750 | TRACOE vario Tracheostomy Tube with Adjustable Neck Flange, fenestrated |
| 04035324027743 | TRACOE vario Tracheostomy Tube with Adjustable Neck Flange, fenestrated |
| 04035324027736 | TRACOE vario Tracheostomy Tube with Adjustable Neck Flange, fenestrated |
| 04035324019342 | TRACOE vario XL Tracheostomy Tube, Extra-Long, with Adjustable Neck Flange and Low Pressure Cuff |
| 04035324019335 | TRACOE vario XL Tracheostomy Tube, Extra-Long, with Adjustable Neck Flange and Low Pressure Cuff |
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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