Identity
- Trade Name
- Trachealator FDA UDI
- Generic Name
- Bronchial balloon catheter FDA UDI
- Device Name
- The Trachealator Non-occlusive Airway Dilation Balloon is comprised of a single lumen, over-the wire, catheter with a clustered balloon system near the distal tip. The balloon cluster, when inflated, features a inter balloon space to avoid airway occlusion during deployment. The inflated balloon cluster generates a strong outward force for dilation of airway strictures. A guidewire is provided to facilitate the advancement of the Trachealator Non-occlusive Airway Dilation Balloon to the desired location. FDA UDI
- Model / Reference
- TRD1 FDA UDI
- Description
- The Trachealator Non-occlusive Airway Dilation Balloon is comprised of a single lumen, over-the wire, catheter with a clustered balloon system near the distal tip. The balloon cluster, when inflated, features a inter balloon space to avoid airway occlusion during deployment. The inflated balloon cluster generates a strong outward force for dilation of airway strictures. A guidewire is provided to facilitate the advancement of the Trachealator Non-occlusive Airway Dilation Balloon to the desired location. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06009698450009 FDA UDI
- 510(k) Number
- K211894 FDA UDI
- FDA Product Code
- KTI FDA UDI
- GMDN Term
- Bronchial balloon catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4680 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Bronchial balloon catheter
Trachealator by Disa Medinotec (pty) Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bronchial balloon catheter.
- MultiStage® — Dongguan TT Medical, Inc. · Class II
- Elation™ — Merit Medical Systems, Inc. · Class II
- INSPIRA AIR — ACCLARENT, INC. · Class II
- Elation™ — Merit Medical Systems, Inc. · Class II
- MultiStage® — Dongguan TT Medical, Inc. · Class II
- UNIBLOCKER — Fuji Systems Corp. · Class II
- INSPIRA AIR — ACCLARENT, INC. · Class II
- Blowfish Micro-Infusion Catheter — Mercator MedSystems, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Disa Medinotec (pty) Ltd
Sources (1)
- FDA UDI ac4a1c3f-d03c-4d30-bdf5-384da1c0b14e 34 fields · synced May 30, 2026