Duns Number:118380146
Device Description: Transpac™ IT Monitoring Kit w/3ml Flush Device, Safeset™ Reservoir, 2 Needleless Valves, M Transpac™ IT Monitoring Kit w/3ml Flush Device, Safeset™ Reservoir, 2 Needleless Valves, Mounts and Bracket
Catalog Number
46110-07
Brand Name
Transpac™
Version/Model Number
46110-07
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
741a5e11-3622-4aea-bc6f-4a3bc3bcf4f2
Public Version Date
August 05, 2021
Public Version Number
1
DI Record Publish Date
July 28, 2021
Package DI Number
10840619067653
Quantity per Package
10
Contains DI Package
00840619067656
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 |