Duns Number:154454730
Catalog Number
MC-1111SS
Brand Name
Small/Medium CPAP Cap Only
Version/Model Number
MC-1111SS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 20, 2021
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
CAT
Product Code Name
Cannula, Nasal, Oxygen
Public Device Record Key
e8a8da01-fbf1-46aa-a559-2fdb79983d7f
Public Version Date
September 21, 2021
Public Version Number
3
DI Record Publish Date
September 11, 2017
Package DI Number
10858409005433
Quantity per Package
12
Contains DI Package
00858409005436
Package Discontinue Date
September 20, 2021
Package Status
Not 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 | 53 |
2 | A medical device with a moderate to high risk that requires special controls. | 5 |