← Back to catalogue

Moore Tracheostomy Tube

FDA UDI

Class II (US FDA UDI)

by Boston Medical Products, Inc.

Identity

Trade Name
Moore Tracheostomy Tube FDA UDI
Generic Name
Tracheostomy tube, non-reinforced, non-customized, reusable FDA UDI
Device Name
Size: 10; Type: Radiopaque FDA UDI
Model / Reference
MTT-010 FDA UDI
Description
Size: 10; Type: Radiopaque FDA UDI

Identifiers

Catalog Number
MTT-010 FDA UDI
Primary DI / UDI-DI
EBESMTT0100 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
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 13 Millimeter FDA UDI
Length — 115 Millimeter FDA UDI
Lumen/Inner Diameter — 8.4 Millimeter FDA UDI

Category: Tracheostomy tube, non-reinforced, non-customized, reusable

Moore Tracheostomy Tube by Boston Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tracheostomy tube, non-reinforced, non-customized, reusable.

Cleared under the same submission

K962240 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Boston Medical Products, Inc.

Sources (1)

  • FDA UDI e7f3ce93-8030-4ee9-be17-23590537bb97 38 fields · synced Jun 9, 2026