Model: FS-103
DI: B448260103
Status: New
MRI: MR Safe
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-13
Current Version: 2026-05-21
Distribution End: 2026-05-13
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a561318c-2ad3-4069-8168-83e6c5cea6a4
Distribution Status:
Not in Commercial Distribution
DUNS Number:
529576331
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
Yes
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
Yes
Labeled Contains NRL:
Yes
Labeled No NRL:
No
Identifiers
Device ID:
B448260103
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 36066
Name: Cardiopulmonary resuscitation mask, reusable
Definition:
A flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS). This is a reusable device.
FDA Product Codes
CBP
Valve, Non-Rebreathing