Duns Number:118380146
Device Description: Transpac™ IT Trifurcated Monitoring Kit w/03 ml Squeeze Flush, Safeset™ Reservoir, 2 Needl Transpac™ IT Trifurcated Monitoring Kit w/03 ml Squeeze Flush, Safeset™ Reservoir, 2 Needleless Valves, Mounts and Bracket
Catalog Number
46107-36
Brand Name
Transpac™
Version/Model Number
46107-36
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
K052828,K052828
Product Code
DRS
Product Code Name
Transducer, blood-pressure, extravascular
Public Device Record Key
c07a49f1-10bc-4112-9816-8e35448ecd17
Public Version Date
August 04, 2021
Public Version Number
1
DI Record Publish Date
July 27, 2021
Package DI Number
10840619065598
Quantity per Package
10
Contains DI Package
00840619065591
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 |