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Invotec Tracheal T-Tube
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 70-50140Ref 70-50120Ref 70-50161Ref 70-500081Ref 70-50100Ref 70-50141
Identity
- Trade Name
- Invotec Tracheal T-Tube FDA UDI
- Generic Name
- Laryngectomy tube, non-sterile FDA UDI
- Device Name
- Tracheal T-Tube EUDAMEDInvotec Tracheal T-Tube, Non-Sterile, 8.0cm Long FDA UDIInvotec Tracheal T-Tube, Non-Sterile, 10.0cm Standard FDA UDIInvotec Tracheal T-Tube, Non-Sterile, 12.0cm Standard FDA UDIInvotec Tracheal T-Tube, Non-Sterile, 14.0cm Long FDA UDIInvotec Tracheal T-Tube, Non-Sterile, 16.0cm Long FDA UDIInvotec Tracheal T-Tube, Non-Sterile, 14.0cm Standard FDA UDI
- Model / Reference
- 70-50140 EUDAMED70-50120 EUDAMED70-50161 EUDAMED70-500081 EUDAMED70-50100 EUDAMED70-50141 EUDAMED1 FDA UDI
- Description
- Invotec Tracheal T-Tube, Non-Sterile, 8.0cm Long FDA UDIInvotec Tracheal T-Tube, Non-Sterile, 10.0cm Standard FDA UDIInvotec Tracheal T-Tube, Non-Sterile, 12.0cm Standard FDA UDIInvotec Tracheal T-Tube, Non-Sterile, 14.0cm Long FDA UDIInvotec Tracheal T-Tube, Non-Sterile, 16.0cm Long FDA UDIInvotec Tracheal T-Tube, Non-Sterile, 14.0cm Standard FDA UDI
Identifiers
- Catalog Number
- 70-50081 FDA UDI70-50100 FDA UDI70-50120 FDA UDI70-50141 FDA UDI70-50161 FDA UDI70-50140 FDA UDI
- Primary DI / UDI-DI
- 00818501020065 EUDAMEDFDA UDI00818501020072 EUDAMEDFDA UDI00818501020096 EUDAMEDFDA UDI00818501020126 EUDAMEDFDA UDI00818501020140 EUDAMEDFDA UDI00818501020119 EUDAMEDFDA UDI
- Basic UDI-DI
- 081850102TrachealtubeQG EUDAMED
- 510(k) Number
- K930114 FDA UDI
- FDA Product Code
- BTR FDA UDI
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
- GMDN Term
- Laryngectomy tube, non-sterile FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5730 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Laryngectomy tube, non-sterile
Invotec Tracheal T-Tube by Invotec International, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Invotec International, Inc.
Sources (12)
- FDA UDI b4c514e5-245d-46ac-87fa-164d27c47f43 35 fields · synced Aug 2, 2026
- FDA UDI 4f4e3e29-a802-41ae-9751-978a854862b5 35 fields · synced May 30, 2026
- FDA UDI 3fe34c8a-b842-4aa6-a3a9-6fc6f384007d 35 fields · synced May 30, 2026
- FDA UDI 0a5adeeb-f358-42f7-b736-426249e0f3b3 35 fields · synced May 30, 2026
- FDA UDI 0f37476b-19f7-405a-9464-4994b72104df 35 fields · synced May 30, 2026
- FDA UDI 3e9163e3-0416-4ac6-baf8-a2773eb18274 35 fields · synced May 30, 2026
- EUDAMED d548fe80-3b39-493d-92f1-415337bc04d2 61 fields · synced Jul 9, 2026
- EUDAMED abdcaf41-e2c7-4e06-a4cb-4f6c0daa9981 61 fields · synced Jul 9, 2026
- EUDAMED bdb52e85-7cac-422e-99a0-abfbcea6cbbf 61 fields · synced Jul 13, 2026
- EUDAMED 3296a4c7-06b3-4918-8107-60bc3167bfef 61 fields · synced Jul 22, 2026
- EUDAMED b74bd3e9-4bd3-446f-80d6-f6dd8f7ec094 61 fields · synced Jul 27, 2026
- EUDAMED 8b32d08a-533b-4a81-9d88-ba2dcbff8cf2 61 fields · synced Aug 2, 2026