Device
GUEDEL AIRWAYS, XXXL ADULT SIZE 7, PURPLE 120MM
Manufacturer
KENTRON HEALTHCARE, INC.
KENTRON HEALTHCARE, INC.
Model: 789120
DI: 00810003751379
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-08
Current Version: 2026-05-18
Description
GUEDEL AIRWAYS, XXXL ADULT SIZE 7, PURPLE 120MM
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0ae6f715-d394-40f8-b82b-b8e290edf8c8
Distribution Status:
In Commercial Distribution
DUNS Number:
618825723
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
BOX
Item #1 - Device ID:
10810003751376
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
50
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00810003751379
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00810003751379
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 42424
Name: Oropharyngeal airway, single-use
Definition:
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.
FDA Product Codes
CAE
Airway, Oropharyngeal, Anesthesiology