TRACOE silcosoft REF 373-5.5-C70
GUDID 04035324031696
Tracheostomy Tube for Children
Tracoe medical GmbH
Tracheostomy tube, non-reinforced, non-customized, single-use| Primary Device ID | 04035324031696 |
| NIH Device Record Key | 225bb7bf-ecef-42ed-856e-81c8b9479dad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRACOE silcosoft |
| Version Model Number | REF 373-5.5-C70 |
| Catalog Number | REF 373-5.5-C70 |
| Company DUNS | 319414785 |
| Company Name | Tracoe medical GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 |
Device Dimensions
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
| Lumen/Inner Diameter | 5.5 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| 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 |
| 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. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04035324031696 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K172720
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 | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2024-10-16 |
| Device Publish Date | 2018-05-24 |
On-Brand Devices [TRACOE silcosoft]
| 04035324031849 | Tracheostomy Tube for Children |
| 04035324032297 | Tracheostomy Tube for Children |
| 04035324032334 | Tracheostomy Tube for Children |
| 04035324032228 | Tracheostomy Tube for Children |
| 04035324031696 | Tracheostomy Tube for Children |
| 04035324031689 | Tracheostomy Tube for Children |
| 04035324031672 | Tracheostomy Tube for Children |
| 04035324031665 | Tracheostomy Tube for Children |
| 04035324031658 | Tracheostomy Tube for Children |
| 04035324031641 | Tracheostomy Tube for Children |
| 04035324031634 | Tracheostomy Tube for Children |
| 04035324031627 | Tracheostomy Tube for Children |
| 04035324031610 | Tracheostomy Tube for Children |
| 04035324031603 | Tracheostomy Tube for Children |
| 04035324031597 | Tracheostomy Tube for Children |
| 04035324031580 | Tracheostomy Tube for Children |
| 04035324031573 | Tracheostomy Tube for Children |
| 04035324031566 | Tracheostomy Tube for Children |
| 04035324031559 | Tracheostomy Tube for Children |
| 04035324031542 | Tracheostomy Tube for Children |
| 04035324031535 | Tracheostomy Tube for Children |
| 04035324031528 | Tracheostomy Tube for Children |
| 04035324031504 | Tracheostomy Tube for Children |
| 04035324031498 | Tracheostomy Tube for Children |
| 04035324031481 | Tracheostomy Tube for Children |
| 04035324031474 | Tracheostomy Tube for Children |
| 04035324031467 | Tracheostomy Tube for Children |
| 04035324031450 | Tracheostomy Tube for Children |
| 04035324031443 | Tracheostomy Tube for Children |
| 04035324031436 | Tracheostomy Tube for Children |
| 04035324031429 | Tracheostomy Tube for Children |
| 04035324031405 | Tracheostomy Tube for Children |
| 04035324031399 | Tracheostomy Tube for Children |
| 04035324031382 | Tracheostomy Tube for Children |
| 04035324031375 | Tracheostomy Tube for Children |
| 04035324031368 | Tracheostomy Tube for Children |
| 04035324031351 | Tracheostomy Tube for Children |
| 04035324031344 | Tracheostomy Tube for Children |
| 04035324031337 | Tracheostomy Tube for Children |
| 04035324031320 | Tracheostomy Tube for Children |
| 04035324031306 | Tracheostomy Tube for Children |
| 04035324031290 | Tracheostomy Tube for Children |
| 04035324031283 | Tracheostomy Tube for Children |
| 04035324031276 | Tracheostomy Tube for Children |
| 04035324031269 | Tracheostomy Tube for Children |
| 04035324031252 | Tracheostomy Tube for Children |
| 04035324031245 | Tracheostomy Tube for Children |
| 04035324031238 | Tracheostomy Tube for Children |
| 04035324031221 | Tracheostomy Tube for Children |
| 04035324031214 | Tracheostomy Tube for Children |
Trademark Results [TRACOE silcosoft]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRACOE SILCOSOFT 79200939 5337590 Live/Registered |
TRACOE medical GmbH 2016-11-15 |
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