AccessGUDID - DEVICE: MediChoice (10885632101328)

GUDID

Device Identifier (DI) Information

Brand Name: MediChoice
Version or Model: GA5080
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OWENS & MINOR DISTRIBUTION, INC.

Primary DI Number: 10885632101328
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007941230 *Terms of Use

Device Description: Airway Guedel Plastic Finish Individually Bagged Single Patient Use Green 80 Millimeter Non-Sterile Not Made With Natural Rubber Latex MediChoice

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:	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?
42424	Oropharyngeal airway, single-use	A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAE	AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 0 and 40 Degrees Celsius
Special Storage Condition, Specify: Avoid freezing and excessive heat
Special Storage Condition, Specify:

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9e0cc9ab-0ab3-4bc2-b332-2003af3c6622
Public Version Date: September 09, 2020
Public Version Number: 1
DI Record Publish Date: September 01, 2020