Identity
- Trade Name
- JEM 350 Endotracheal Tube Changer 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 350 fits tubes with 5.0mm Inside Diameter. FDA UDI
- Model / Reference
- JEM 350 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 350 fits tubes with 5.0mm Inside Diameter. FDA UDI
Identifiers
- Catalog Number
- JEM 350 FDA UDI
- Primary DI / UDI-DI
- M996JEM3500 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 4.55 Millimeter FDA UDI
Category: Endotracheal tube guide, single-use
JEM 350 Endotracheal Tube Changer by Instrumentation Industries, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 fd24216b-e1ad-46b2-9fd2-b80f8f0b43fa 36 fields · synced May 30, 2026