Duns Number:632707092
Catalog Number
-
Brand Name
Anesthesia mask disp, size 5
Version/Model Number
6694267
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 10, 2019
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
b3390ad8-3f20-4877-b73c-a33a5c2aee02
Public Version Date
September 11, 2019
Public Version Number
3
DI Record Publish Date
December 10, 2015
Package DI Number
17325710001995
Quantity per Package
20
Contains DI Package
07325710001998
Package Discontinue Date
September 10, 2019
Package Status
Not 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 | 62 |
2 | A medical device with a moderate to high risk that requires special controls. | 131 |