Duns Number:198013435
Device Description: Nasal Respiratory Support (Qty. 10)
Catalog Number
N4901
Brand Name
Ram Cannula Preemie
Version/Model Number
10812594011273
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
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
1f55f4b8-fdeb-42ac-8f5f-c2bbe3b2ff8f
Public Version Date
July 26, 2022
Public Version Number
4
DI Record Publish Date
May 19, 2021
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 | 153 |
2 | A medical device with a moderate to high risk that requires special controls. | 27 |