Duns Number:206449154
Device Description: O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventil O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/manual resuscitator or anesthesia machine to provide a mask to face seal which covers both mouth and nose during resuscitation or anesthesia. The clear Silicone facemasks are ideal for anesthesia as they withstand repeated autoclaving. The universal silicone mask 02FM5097 fits patients from infant to Adult adult.
Catalog Number
02FM5097-CS
Brand Name
O-Two
Version/Model Number
02FM5097
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
-
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
8296ef93-44d9-49a9-859e-b1fca983f491
Public Version Date
October 24, 2019
Public Version Number
1
DI Record Publish Date
October 16, 2019
Package DI Number
17540195010106
Quantity per Package
12
Contains DI Package
07540195010109
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 |