TRACOE® mini
GUDID 04035324032365
Tracheostomy Tube for Children
Tracoe medical GmbH
Tracheostomy tube, non-reinforced, non-customized, single-use| Primary Device ID | 04035324032365 |
| NIH Device Record Key | 50753f93-65b5-42df-ac43-3738a25f627f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRACOE® mini |
| Version Model Number | REF 355-6.0-C80 |
| 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 | true |
| 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 |
Device Dimensions
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 6 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 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04035324032365 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K893866
FDA Product Code
| BTO | Tube, tracheostomy (w/wo connector) |
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 | 2022-01-28 |
| Device Publish Date | 2022-01-20 |
On-Brand Devices [TRACOE® mini]
| 04035324032372 | Tracheostomy Tube for Children |
| 04035324032365 | Tracheostomy Tube for Children |
| 04035324028702 | Tracheostomy Tube for Neonates |
| 04035324028696 | Tracheostomy Tube for Neonates |
| 04035324028689 | Tracheostomy Tube for Neonates, product variation |
| 04035324028047 | Tracheostomy Tube for Neonates |
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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