Duns Number:002348191
Device Description: Arrow(R) VPS(R) Stylet Bedside Procedure Kit
Catalog Number
VPS-0072-BPK
Brand Name
ARROW
Version/Model Number
IPN039773
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K103255,K103255
Product Code
OBJ
Product Code Name
Catheter, ultrasound, intravascular
Public Device Record Key
a1d358dd-22ec-4dc0-b48f-4b401277ec2c
Public Version Date
May 19, 2020
Public Version Number
2
DI Record Publish Date
April 10, 2019
Package DI Number
20801902145776
Quantity per Package
5
Contains DI Package
10801902145779
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 |