Device
AEROSOL MASK ELONGATED, PEDIATRIC, LATEX FREE.
Manufacturer
KENTRON HEALTHCARE, INC.
KENTRON HEALTHCARE, INC.
Model: 333110
DI: 00810003755995
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-17
Current Version: 2026-05-25
Description
AEROSOL MASK ELONGATED, PEDIATRIC, LATEX FREE.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
8c6d9bef-7e7a-4a35-bdae-bf9b64a7095f
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:
CASE
Item #1 - Device ID:
10810003755992
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
50
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00810003755995
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00810003755995
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 35142
Name: Aerosol face mask, rebreathing, single-use
Definition:
A flexible, form-shaped device that is placed over the nose and mouth to deliver aerosolized particles/gases to a patient's airway. It is typically used in conjunction with a nebulizer or medicine chamber spacer for the delivery of medication in either a healthcare or home setting. It is made of high-grade resins or other materials to produce a soft, flexible mask that will create an airtight seal against the patient's face. It may include a headstrap and is available in a range of sizes. This is a single-use device.
FDA Product Codes
BYG
Mask, Oxygen