Duns Number:002348191
Device Description: Prep Kit with Sharps Safety Features and Maximal Barrier Precautions
Catalog Number
ASK-04001-HHCT
Brand Name
ARROW
Version/Model Number
IPN036430
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
K003006,K003006
Product Code
LJT
Product Code Name
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Public Device Record Key
df4c5206-2328-4f04-8e43-40aa8de842c4
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
40801902123235
Quantity per Package
5
Contains DI Package
10801902123234
Package Discontinue Date
April 09, 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 |