TRACOE® care
GUDID 04035324012886
TRACOE purofoam Tracheostomy Dressing small
Tracoe medical GmbH
Tracheostomy tube dressing| Primary Device ID | 04035324012886 |
| NIH Device Record Key | 8662263f-d7d1-4fda-ba6c-9209185f548c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRACOE® care |
| Version Model Number | REF 959 |
| 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 | 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 |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 6.5 Centimeter |
| Width | 6.5 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6.5 Centimeter |
| Width | 6.5 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6.5 Centimeter |
| Width | 6.5 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6.5 Centimeter |
| Width | 6.5 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6.5 Centimeter |
| Width | 6.5 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6.5 Centimeter |
| Width | 6.5 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6.5 Centimeter |
| Width | 6.5 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6.5 Centimeter |
| Width | 6.5 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6.5 Centimeter |
| Width | 6.5 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6.5 Centimeter |
| Width | 6.5 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *no special storage conditions |
| Special Storage Condition, Specify | Between 0 and 0 *no special storage conditions |
| Special Storage Condition, Specify | Between 0 and 0 *no special storage conditions |
| Special Storage Condition, Specify | Between 0 and 0 *no special storage conditions |
| Special Storage Condition, Specify | Between 0 and 0 *no special storage conditions |
| Special Storage Condition, Specify | Between 0 and 0 *no special storage conditions |
| Special Storage Condition, Specify | Between 0 and 0 *no special storage conditions |
| Special Storage Condition, Specify | Between 0 and 0 *no special storage conditions |
| Special Storage Condition, Specify | Between 0 and 0 *no special storage conditions |
| Special Storage Condition, Specify | Between 0 and 0 *no special storage conditions |
| Special Storage Condition, Specify | Between 0 and 0 *no special storage conditions |
| Special Storage Condition, Specify | Between 0 and 0 *no special storage conditions |
| Special Storage Condition, Specify | Between 0 and 0 *no special storage conditions |
| Special Storage Condition, Specify | Between 0 and 0 *no special storage conditions |
| Special Storage Condition, Specify | Between 0 and 0 *no special storage conditions |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04035324012886 [Primary] |
| GS1 | 05701780328586 [Unit of Use] |
FDA Product Code
| NAD | Dressing,wound,occlusive |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2021-01-22 |
| Device Publish Date | 2016-03-15 |
On-Brand Devices [TRACOE® care]
| 04035324063819 | Two-Ply Tracheal compresses without slit |
| 04035324061310 | Tracheal Compresses with zigzag slit |
| 04035324061211 | Tracheal Compresses without slit |
| 04035324047413 | Tracheal Compresses, Aluminium coated, with zigzag slit |
| 04035324012886 | TRACOE purofoam Tracheostomy Dressing small |
| 04035324012862 | TRACOE purofoam Tracheostomy Dressing large |
| 04035324012572 | Tracheal Compresses with zigzag slit, for neonates and children |
| 04035324011629 | Coated Tracheal Compresses with zigzag slit |
| 04035324011605 | Coated Two-Ply Tracheal Compresses with zigzag slit |
| 04035324061112 | TRACOE tube clean Cleaning tub |
| 04035324060917 | TRACOE tube clean Cleaning powder |
| 04035324012268 | TRACOE cleaning brushes for flexible tracheostomy tubes set |
| 04035324012206 | TRACOE cleaning brushes with wool tip set |
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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