Duns Number:022721133
Device Description: Nasel cannula, (pediatric) Maximum Input Flow 8 L/min
Catalog Number
270.998
Brand Name
n/a
Version/Model Number
SO-1977
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"
Yes
For Single-Use
-
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
CAT
Product Code Name
CANNULA, NASAL, OXYGEN
Public Device Record Key
82e0f5a4-c629-42a6-9dbd-ed708dba6fcc
Public Version Date
March 22, 2022
Public Version Number
3
DI Record Publish Date
November 30, 2016
Package DI Number
10607411918121
Quantity per Package
25
Contains DI Package
00607411918124
Package Discontinue Date
-
Package Status
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 | 865 |
2 | A medical device with a moderate to high risk that requires special controls. | 1134 |