Duns Number:002348191
Device Description: THERMODILUTION CATH KIT: 7.5 FR 5-L
Catalog Number
AH-05050
Brand Name
ARROW
Version/Model Number
IPN000030
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
K895268,K895268
Product Code
DYG
Product Code Name
CATHETER, FLOW DIRECTED
Public Device Record Key
a814b698-3fef-4dae-aa17-5c5fcd2ab94f
Public Version Date
March 10, 2021
Public Version Number
7
DI Record Publish Date
September 16, 2016
Package DI Number
30801902003974
Quantity per Package
5
Contains DI Package
00801902003973
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 |