Duns Number:149818952
Device Description: Universal II Slittable Inner Catheter (Subselector)
Catalog Number
DS2N100-59
Brand Name
CPS AIM™
Version/Model Number
DS2N100-59
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
K221750
Product Code
DQY
Product Code Name
Catheter, percutaneous
Public Device Record Key
4c5011f3-c823-47a0-a58c-2b4a5839d95d
Public Version Date
October 28, 2022
Public Version Number
1
DI Record Publish Date
October 20, 2022
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 | 70 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1429 |
| 3 | A medical device with high risk that requires premarket approval | 736 |