Duns Number:926603486
Device Description: are rubber or silicone masks that cover both the mouth and nose of the patient.
Catalog Number
DU1073
Brand Name
Anesthesia Mask (Medium)
Version/Model Number
1
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
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
b773c468-468d-40e3-a8d3-17b19e865156
Public Version Date
August 14, 2020
Public Version Number
1
DI Record Publish Date
August 06, 2020
Package DI Number
10850014433120
Quantity per Package
100
Contains DI Package
00850014433123
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |