Duns Number:092673953
Device Description: Comfort Soft Plus Anesthesia Mask Large Adult w/Hook Ring
Catalog Number
-
Brand Name
Anesthesia Mask
Version/Model Number
7-9910
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)
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
4ca713ec-c43d-4633-87ee-9504f3633320
Public Version Date
October 28, 2019
Public Version Number
1
DI Record Publish Date
October 18, 2019
Package DI Number
10709078008143
Quantity per Package
30
Contains DI Package
00709078008146
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 | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |