Duns Number:206449154
Device Description: O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventil
Catalog Number
02FM5099-CS
Brand Name
O-Two
Version/Model Number
02FM5099
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
ae38b454-bcd9-4dd6-b14f-96787f302612
Public Version Date
October 24, 2019
Public Version Number
1
DI Record Publish Date
October 16, 2019
Package DI Number
17540195010120
Quantity per Package
12
Contains DI Package
07540195010123
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 |