Pilot Tube Repair Kit

FDA UDI

Class II (US FDA UDI)

by Instrumentation Industries, Incorporated

Identity

Trade Name: Pilot Tube Repair Kit FDA UDI
Generic Name: Tracheal pilot tube repair kit FDA UDI
Device Name: Pilot tube repair kit is used to repair a leaking pilot line of endotracheal and tracheostomy tubes with inside diameters of 0.032 inch (21 gauge) to 0.050 inch (18 gauge). Use of a pilot tube repair kit can delay the replacement of the endotracheal or tracheostomy tube thus reducing trauma to the patient. FDA UDI
Model / Reference: BE 409 FDA UDI
Description: Pilot tube repair kit is used to repair a leaking pilot line of endotracheal and tracheostomy tubes with inside diameters of 0.032 inch (21 gauge) to 0.050 inch (18 gauge). Use of a pilot tube repair kit can delay the replacement of the endotracheal or tracheostomy tube thus reducing trauma to the patient. FDA UDI

Identifiers

Catalog Number: BE 409 FDA UDI
Primary DI / UDI-DI: M996BE4090 FDA UDI
FDA Product Code: BSK FDA UDI
GMDN Term: Tracheal pilot tube repair kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5750 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Tracheal pilot tube repair kit

Pilot Tube Repair Kit by Instrumentation Industries, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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: Instrumentation Industries, Incorporated

Sources (1)

FDA UDI 655a4a83-e7cc-452c-9015-7de492edfd78 35 fields · synced May 30, 2026