FDA UDI
In Commercial Distribution
🇺🇸 United States
JEM 370 Endotracheal Tube Changer
DI: M996JEM3700
·
Model: JEM 370
·
INSTRUMENTATION INDUSTRIES, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- JEM 370 Endotracheal Tube Changer
- Primary DI
- M996JEM3700
- Version / Model
- JEM 370
- Catalog Number
- JEM 370
- Company Name
- INSTRUMENTATION INDUSTRIES, INCORPORATED
- Labeler DUNS
- 053146767
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2020-11-25
- Public Version Status
- Update
- Public Device Record Key
- 0ad19476-81af-4943-8442-c525aef5448e
Device 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 370 fits tubes with 7.0mm Inside Diameter.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide, High-level Disinfectant, Hydrogen Peroxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LNZ | Changer, Tube, Endotracheal | Anesthesiology | 868.5730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42084 | Endotracheal tube guide, single-use | A device used to provide guidance when it is necessary to exchange an endotracheal (ET) tube which has been intubated into a patient. The guide is inserted into the existing tube which is then retracted over the guide. The new ET tube is inserted over the guide to facilitate its correct passage, and the guide is removed once the new tube is satisfactorily in place. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M996JEM3702 | HIBCC | Heat-sealed poly bag | 10 | In Commercial Distribution | |
| Primary | M996JEM3700 | HIBCC |
Customer Contacts
- Phone
- 412-854-1133
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 5.54 | Millimeter |