Duns Number:002348191
Device Description: Percutaneous Insertion Kit
Catalog Number
IAK-06845
Brand Name
ARROW
Version/Model Number
IPN914077
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
K000729,K000729
Product Code
DSP
Product Code Name
System, balloon, intra-aortic and control
Public Device Record Key
332d0b47-e2c4-4f91-a5cb-246d1ed00394
Public Version Date
May 28, 2020
Public Version Number
3
DI Record Publish Date
December 05, 2018
Package DI Number
10801902142433
Quantity per Package
1
Contains DI Package
20801902142430
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |