Duns Number:002348191
Device Description: PSI Kit for use with 7.5 - 8 Fr. Catheters / Arrowg+ard Blue(R) One-Lumen CVC Kit
Catalog Number
ASK-01409-JHH1
Brand Name
ARROW
Version/Model Number
IPN038381
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
a09f1792-e3f1-4a60-8eea-73fa7fa57d2f
Public Version Date
January 25, 2022
Public Version Number
6
DI Record Publish Date
March 09, 2018
Package DI Number
20801902139690
Quantity per Package
3
Contains DI Package
10801902139693
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 |