Identity
- Trade Name
- Moore Tracheostomy Tube FDA UDI
- Generic Name
- Tracheostomy tube, non-reinforced, non-customized, reusable FDA UDI
- Device Name
- Size: 8; Type: Radiopaque FDA UDI
- Model / Reference
- MTT-008 FDA UDI
- Description
- Size: 8; Type: Radiopaque FDA UDI
Identifiers
- Catalog Number
- MTT-008 FDA UDI
- Primary DI / UDI-DI
- EBESMTT0080 FDA UDI
- 510(k) Number
- K962240 FDA UDI
- FDA Product Code
- BTO FDA UDI
- GMDN Term
- Tracheostomy tube, non-reinforced, non-customized, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 12 Millimeter FDA UDILength — 115 Millimeter FDA UDILumen/Inner Diameter — 7.4 Millimeter FDA UDI
Category: Tracheostomy tube, non-reinforced, non-customized, reusable
Moore Tracheostomy Tube by Boston Medical Products, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Tracheostomy tube, non-reinforced, non-customized, reusable.
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- Bivona — ICU MEDICAL, INC. · Class II
- Bivona — ICU MEDICAL, INC. · Class II
- Bivona — ICU MEDICAL, INC. · Class II
- Bivona — ICU MEDICAL, INC. · Class II
- Bivona — ICU MEDICAL, INC. · Class II
- Bivona — ICU MEDICAL, INC. · Class II
- Bivona — ICU MEDICAL, INC. · Class II
Cleared under the same submission
K962240 also covers:
- Moore Tracheostomy Tube — Boston Medical Products, Inc.
- Moore Tracheostomy Tube — Boston Medical Products, Inc.
- Moore Tube 15 mm Inner Cannula — Boston Medical Products, Inc.
- Moore Tube 15 mm Inner Cannula — Boston Medical Products, Inc.
- Moore Tube 15 mm Inner Cannula — Boston Medical Products, Inc.
- Moore Tube Low-Profile Inner Cannula — Boston Medical Products, Inc.
- Moore Tube Low-Profile Inner Cannula — Boston Medical Products, Inc.
- Moore Tube Low-Profile Inner Cannula — Boston Medical Products, Inc.
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
- Boston Medical Products, Inc.
Sources (2)
- FDA UDI 3db2f831-6eb7-48eb-bf36-361fce35f3d0 38 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026