AccessGUDID - DEVICE: JEM 401 Set of Endotracheal Tube Changers, (includes 9 sizes) (M996JEM4010)

GUDID

Device Identifier (DI) Information

Brand Name: JEM 401 Set of Endotracheal Tube Changers, (includes 9 sizes)
Version or Model: JEM 401
Commercial Distribution Status: In Commercial Distribution
Catalog Number: JEM 401
Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED

Primary DI Number: M996JEM4010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053146767 *Terms of Use

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 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LNZ	Changer, Tube, Endotracheal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide
High-level Disinfectant
Hydrogen Peroxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 6.43 Millimeter
Outer Diameter: 5.54 Millimeter
Outer Diameter: 4.55 Millimeter
Outer Diameter: 3.56 Millimeter
Outer Diameter: 2.57 Millimeter
Outer Diameter: 1.80 Millimeter

Device Record Status

Public Device Record Key: 6297e39c-5226-40eb-bf23-79a6bf0aa5f7
Public Version Date: November 25, 2020
Public Version Number: 3
DI Record Publish Date: September 24, 2016