AccessGUDID - DEVICE: Merlyn EndoTube (00182151000266)

GUDID

Device Identifier (DI) Information

Brand Name: Merlyn EndoTube
Version or Model: Preformed Oral 420080
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 420080
Company Name: MERLYN ASSOCIATES, INC.

Primary DI Number: 00182151000266
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 606864184 *Terms of Use

Device Description: 8.0mm ID preformed oral cuffed endotracheal tube with Magill curve, radiopaque line and smooth Murphy tip

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
46967	Basic endotracheal tube, single-use	A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated; it does not include an antimicrobial agent(s). The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTR	Tube, Tracheal (W/Wo Connector)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K042683	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 32 and 120 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 8.0 Millimeter

Device Record Status

Public Device Record Key: 27bb4e36-ac62-452a-bdcc-fddc8098b3e0
Public Version Date: June 19, 2020
Public Version Number: 4
DI Record Publish Date: June 01, 2016