| Primary Device ID | 04035324019069 |
| NIH Device Record Key | 2abe96d0-9add-41c0-b158-8cbf0ff12c34 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRACOE mini |
| Version Model Number | REF 356 |
| Catalog Number | REF 356 |
| Company DUNS | 319414785 |
| Company Name | Tracoe medical GmbH |
| 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 | false |
| 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 |
| 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 |
| 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 30 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 30 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 30 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 30 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 30 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 30 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 30 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 30 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 30 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 30 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 30 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 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04035324019069 [Primary] |
| BZA | CONNECTOR, AIRWAY (EXTENSION) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2025-01-21 |
| Device Publish Date | 2015-10-18 |
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| 04035324016846 | Tracheostomy Tube for Children |
| 04035324016839 | Tracheostomy Tube for Children |
| 04035324016303 | Tracheostomy Tube for Children |
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| 04035324016051 | Tracheostomy Tube for Children |
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| 04035324016037 | Tracheostomy Tube for Children |
| 04035324016020 | Tracheostomy Tube for Children |
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| 04035324015986 | Tracheostomy Tube for Children |
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| 04035324015955 | Tracheostomy Tube for Children |
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| 04035324015931 | Tracheostomy Tube for Children |
| 04035324015924 | Tracheostomy Tube for Children |
| 04035324015917 | Tracheostomy Tube for Children |
| 04035324015900 | Tracheostomy Tube for Children |
| 04035324015894 | Tracheostomy Tube for Children |
| 04035324015887 | Tracheostomy Tube for Children |
| 04035324015870 | Tracheostomy Tube for Children |
| 04035324015863 | Tracheostomy Tube for Children |
| 04035324015856 | Tracheostomy Tube for Children |
| 04035324015849 | Tracheostomy Tube for Children |
| 04035324015832 | Tracheostomy Tube for Children |
| 04035324015825 | Tracheostomy Tube for Children |
| 04035324015801 | Tracheostomy Tube for Children |