Identity
- Trade Name
- JEM 365 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 365 fits tubes with 6.5mm Inside Diameter. FDA UDI
- Model / Reference
- JEM 365 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 365 fits tubes with 6.5mm Inside Diameter. FDA UDI
Identifiers
- Catalog Number
- JEM 365 FDA UDI
- Primary DI / UDI-DI
- M996JEM3650 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 — 5.54 Millimeter FDA UDI
Category: Endotracheal tube guide, single-use
JEM 365 Endotracheal Tube Changer by Instrumentation Industries, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endotracheal tube guide, single-use.
- VYGON — Vygon Corp. · Class I
- Cook — COOK INCORPORATED · Class II
- Arndt — COOK INCORPORATED · Class II
- Aintree — COOK INCORPORATED · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- Arndt — COOK INCORPORATED · Class I
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Instrumentation Industries, Incorporated
Sources (1)
- FDA UDI d13f7efe-3656-4bea-888c-f4c37c3bf5ea 36 fields · synced May 31, 2026