Duns Number:002348191
Device Description: PSI Kit for use with 7 - 7.5 Fr. Catheters
Catalog Number
ASK-09810-PCMH1
Brand Name
ARROW
Version/Model Number
IPN919668
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)
Yes
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
K780532,K780532
Product Code
DYB
Product Code Name
Introducer, catheter
Public Device Record Key
fd4aee01-f7c1-433c-9e19-93552f1bc007
Public Version Date
December 22, 2021
Public Version Number
1
DI Record Publish Date
December 10, 2021
Package DI Number
20801902189831
Quantity per Package
5
Contains DI Package
10801902189834
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |