Duns Number:002348191
Device Description: Temporary Pacing Catheter with Shrouded Pins/Introducer Kit
Catalog Number
ASK-07155-UPM
Brand Name
ARROW
Version/Model Number
IPN001009
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
K945229,K945229
Product Code
DRF
Product Code Name
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Public Device Record Key
019184af-7ed8-4395-834f-d8edb00dc30a
Public Version Date
April 08, 2022
Public Version Number
8
DI Record Publish Date
September 16, 2016
Package DI Number
30801902085284
Quantity per Package
5
Contains DI Package
00801902085283
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 |