Duns Number:154454730
Catalog Number
MC-1212
Brand Name
Large CPAP Cap Only
Version/Model Number
MC-1212
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 16, 2020
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
7baeebb9-db6f-4f8a-abbd-cbfd823fc71a
Public Version Date
September 17, 2020
Public Version Number
3
DI Record Publish Date
September 11, 2017
Package DI Number
10858409005273
Quantity per Package
12
Contains DI Package
00858409005276
Package Discontinue Date
September 16, 2020
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 |