Duns Number:088302096
Catalog Number
33034-16-CAP
Brand Name
ClearView Nasal Mask and Capnography Bundle – Large Adult Fresh Mint (pkg. of 12
Version/Model Number
33034-16-CAP
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
August 10, 2199
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
KHA
Product Code Name
Mask, Scavenging
Public Device Record Key
ecf8712c-8bad-444c-9a6f-c5c18510987d
Public Version Date
August 18, 2020
Public Version Number
1
DI Record Publish Date
August 10, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 344 |
2 | A medical device with a moderate to high risk that requires special controls. | 192 |