Duns Number:206449154
Device Description: The Single-use cuff mask comes with an air cushion pad to provide comfort for the patient. The Single-use cuff mask comes with an air cushion pad to provide comfort for the patient. It is designed to be positioned over a patient’s nose or mouth to direct oxygen or anesthetic gases or aerosols to the upper airway. The size #0 cuff mask 02FM5203 fits Neonate patients.
Catalog Number
02FM5206-CS
Brand Name
O-Two
Version/Model Number
02FM5206
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BSJ
Product Code Name
Mask, Gas, Anesthetic
Public Device Record Key
ebf2545a-e4ad-45a8-a3a0-d7045fe202e7
Public Version Date
October 24, 2019
Public Version Number
1
DI Record Publish Date
October 16, 2019
Package DI Number
17540195010328
Quantity per Package
12
Contains DI Package
07540195010321
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |
| U | Unclassified | 3 |