Duns Number:002348191
Device Description: Pressure Injectable Arrowg+ard Blue Advance(R) One-Lumen Midline
Catalog Number
PR-41552-BAS
Brand Name
ARROW
Version/Model Number
IPN919547
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
K161313,K161313
Product Code
PND
Product Code Name
Midline catheter
Public Device Record Key
14e583da-a53c-4753-bdec-a468f91baa7f
Public Version Date
December 22, 2021
Public Version Number
1
DI Record Publish Date
December 14, 2021
Package DI Number
20801902188414
Quantity per Package
5
Contains DI Package
10801902188417
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 |