TRACOE® technic
GUDID 04035324046317
TRACOE Connection tube
Tracoe medical GmbH
Artificial airway cuff inflation tubing| Primary Device ID | 04035324046317 |
| NIH Device Record Key | 0ccbf3b2-cf6b-4214-a6de-0973775c0b11 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRACOE® technic |
| Version Model Number | REF 702 |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
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 |
Device Dimensions
| Length | 1 Meter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from rain. Keep away from sunlight. 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 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 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 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 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 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 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 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 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 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 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 resterilize. |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04035324046317 [Primary] |
| GS1 | 05701780328432 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152778
FDA Product Code
| BSK | Cuff, tracheal tube, inflatable |
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 | 2019-09-27 |
| Device Publish Date | 2019-09-19 |
Devices Manufactured by Tracoe medical GmbH
| 04035324011568 - TRACOE care | 2025-01-21 Two-Ply Tracheal compresses with zigzag slit |
| 04035324019069 - TRACOE mini | 2025-01-21 TRACOE® mini Extension Piece |
| 04035324047710 - TRACOE care | 2025-01-21 TRACOE Tracheostoma Protection small |
| 04035324047819 - TRACOE care | 2025-01-21 TRACOE Tracheostoma Protection large |
| 04035324014903 - TRACOE care | 2024-12-12 Neck Strap - 10 units |
| 04035324000319 - TRACOE comfort | 2024-11-29 Tube without Inner Cannula |
| 04035324000418 - TRACOE comfort | 2024-11-29 Tube without Inner Cannula |
| 04035324000517 - TRACOE comfort | 2024-11-29 Tube without Inner Cannula |
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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