JEM 401 Set of Endotracheal Tube Changers, (includes 9 sizes)

FDA UDI

Class II (US FDA UDI)

by Instrumentation Industries, Incorporated

Identity

Trade Name: JEM 401 Set of Endotracheal Tube Changers, (includes 9 sizes) FDA UDI
Generic Name: Endotracheal tube guide, single-use FDA UDI
Device Name: JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. JEM 401 is a set of nine individually packaged endotracheal tube changers, with each fitting a different size endotracheal tube. The JEM 401 includes one each of JEM 325, JEM 330, JEM 340, JEM 350, JEM 355, JEM 360, JEM 365, JEM 370, JEM 400. FDA UDI
Model / Reference: JEM 401 FDA UDI
Description: JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. JEM 401 is a set of nine individually packaged endotracheal tube changers, with each fitting a different size endotracheal tube. The JEM 401 includes one each of JEM 325, JEM 330, JEM 340, JEM 350, JEM 355, JEM 360, JEM 365, JEM 370, JEM 400. FDA UDI

Identifiers

Catalog Number: JEM 401 FDA UDI
Primary DI / UDI-DI: M996JEM4010 FDA UDI
FDA Product Code: LNZ FDA UDI
GMDN Term: Endotracheal tube guide, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5730 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

Dimensions & Sizes

Size: Outer Diameter — 6.43 Millimeter FDA UDI
Outer Diameter — 5.54 Millimeter FDA UDI
Outer Diameter — 4.55 Millimeter FDA UDI
Outer Diameter — 3.56 Millimeter FDA UDI
Outer Diameter — 2.57 Millimeter FDA UDI
Outer Diameter — 1.80 Millimeter FDA UDI

Category: Endotracheal tube guide, single-use

JEM 401 Set of Endotracheal Tube Changers, (includes 9 sizes) by Instrumentation Industries, Incorporated — Class II — FDA UDI — listed in FDA GUDID

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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 6297e39c-5226-40eb-bf23-79a6bf0aa5f7 36 fields · synced May 31, 2026