Duns Number:118380146
Device Description: Transpac® IV Monitoring Kit, 60", Disposable Transducer, 3 ML Intraflo® Flush, Macrodrip ( Transpac® IV Monitoring Kit, 60", Disposable Transducer, 3 ML Intraflo® Flush, Macrodrip (Pole Mount)
Catalog Number
-
Brand Name
Transpac
Version/Model Number
42587-05
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K932188,K932188
Product Code
KRA
Product Code Name
Catheter, continuous flush
Public Device Record Key
a7c330c8-aa23-4993-af49-5d18d156fb27
Public Version Date
April 07, 2021
Public Version Number
7
DI Record Publish Date
December 18, 2017
Package DI Number
10840619033559
Quantity per Package
20
Contains DI Package
00840619033552
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4887 |