Duns Number:002348191
Device Description: PSI Kit Cath-Gard(R) for use with 7.5 - 8 Fr. Catheters
Catalog Number
CDC-09803-1A
Brand Name
ARROW
Version/Model Number
IPN036456
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
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
5a9609e4-c17d-45c8-acbc-f399b47191c6
Public Version Date
June 07, 2019
Public Version Number
4
DI Record Publish Date
May 15, 2018
Package DI Number
20801902116714
Quantity per Package
5
Contains DI Package
30801902116711
Package Discontinue Date
October 24, 2018
Package Status
Not 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 |