Duns Number:118380146
Device Description: Cardiac Catheterization Right Heart Kit With 2-Station Right Hand, On, High Pressure Manif Cardiac Catheterization Right Heart Kit With 2-Station Right Hand, On, High Pressure Manifold And Transpac IT
Catalog Number
460830403
Brand Name
Transpac™
Version/Model Number
460830403
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"
-
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
972d804e-6417-4c4e-a8d1-47d809f797c0
Public Version Date
August 04, 2021
Public Version Number
1
DI Record Publish Date
July 27, 2021
Package DI Number
10840619045217
Quantity per Package
10
Contains DI Package
00840619045210
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 |