Duns Number:118380146
Device Description: Transpac™ IT Monitoring Kit w/Safeset™ 84" Arterial Pressure Tubing, Reservoir, 3ml Squeez Transpac™ IT Monitoring Kit w/Safeset™ 84" Arterial Pressure Tubing, Reservoir, 3ml Squeeze Flush and 2 Needleless Valves
Catalog Number
47100-02
Brand Name
Transpac
Version/Model Number
47100-02
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
1cd15d1b-7541-479f-a8c6-792a111c4898
Public Version Date
November 29, 2021
Public Version Number
1
DI Record Publish Date
November 20, 2021
Package DI Number
10887709123967
Quantity per Package
20
Contains DI Package
00887709123960
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 4887 |