Duns Number:656117801
Catalog Number
-
Brand Name
PAHSCO
Version/Model Number
O02889
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JOL
Product Code Name
Catheter And Tip, Suction
Public Device Record Key
22402a63-2164-486f-873c-7af94a4c2395
Public Version Date
April 20, 2020
Public Version Number
3
DI Record Publish Date
June 04, 2018
Package DI Number
14719873431868
Quantity per Package
50
Contains DI Package
04719873431861
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 21 |