Duns Number:118380146
Device Description: Cardiac Catheterization Basic Kit With Transpac™ IT and 3-Station, Right, ON, High Pressur Cardiac Catheterization Basic Kit With Transpac™ IT and 3-Station, Right, ON, High Pressure Manifold
Catalog Number
460730411
Brand Name
Transpac™
Version/Model Number
460730411
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
da88d90b-a1ce-4240-bccb-33a6e3c6d91b
Public Version Date
August 04, 2021
Public Version Number
1
DI Record Publish Date
July 27, 2021
Package DI Number
10840619040878
Quantity per Package
10
Contains DI Package
00840619040871
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 |