Duns Number:022721133
Device Description: Patient Cannula Kit
Catalog Number
SO-2045
Brand Name
N/A
Version/Model Number
SO-2045
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
0b3ae189-13f8-42dc-94e5-0657e2f776ef
Public Version Date
March 22, 2022
Public Version Number
3
DI Record Publish Date
February 10, 2017
Package DI Number
10607411919029
Quantity per Package
10
Contains DI Package
00607411919022
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 |