Duns Number:002348191
Device Description: Pressure Injectable Arrowg+ard Blue Plus(R) Four-Lumen CVC Kit
Catalog Number
ASK-42854-PRR
Brand Name
ARROW
Version/Model Number
IPN036588
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K071538,K071538,K071538
Product Code
FOZ
Product Code Name
Catheter, intravascular, therapeutic, short-term less than 30 days
Public Device Record Key
ec2de267-6784-441a-af42-e694efda17fb
Public Version Date
January 04, 2022
Public Version Number
1
DI Record Publish Date
December 27, 2021
Package DI Number
20801902116035
Quantity per Package
5
Contains DI Package
30801902116032
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 |