Device
BERMAN AIRWAY, COLOR CODED, 50MM, SIZE 0, LT BLUE, ISO SIZE 5, INFANTS USE
Manufacturer
KENTRON HEALTHCARE, INC.
Model: 779950CC DI: 00810003751928 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: No OTC: Yes
First Published: 2026-05-07 Current Version: 2026-05-15
Description
BERMAN AIRWAY, COLOR CODED, 50MM, SIZE 0, LT BLUE, ISO SIZE 5, INFANTS USE
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: a02897a8-01c5-4007-ac64-b47dd9b1d6c1
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: 10810003751925
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 50
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 00810003751928
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00810003751928
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
Item #3 - Pkg Type: CASE
Item #3 - Device ID: 20810003751922
Item #3 - Pkg Status: In Commercial Distribution
Item #3 - Pkg Quantity: 10
Item #3 - Device ID Type: Package
Item #3 - Contains DINumber: 10810003751925
Item #3 - 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