Duns Number:118380146
Device Description: Cardiac Catheterization Right Heart Kit w/2 Station Right Hand, On, High Pressure Manifold Cardiac Catheterization Right Heart Kit w/2 Station Right Hand, On, High Pressure Manifold (600 psi)
Catalog Number
46300-50
Brand Name
ICU Medical
Version/Model Number
46300-50
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
K932141,K932141
Product Code
DQO
Product Code Name
Catheter, intravascular, diagnostic
Public Device Record Key
301a01e5-1928-4775-a2a1-eb88950ff24e
Public Version Date
September 06, 2021
Public Version Number
1
DI Record Publish Date
August 29, 2021
Package DI Number
10887709089478
Quantity per Package
10
Contains DI Package
00887709089471
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4887 |