Duns Number:118380146
Device Description: Transpac IT Monitoring Kit, 84" Safeset Reservoir, 2 Blood Sampling Port, 3ml Flush Device Transpac IT Monitoring Kit, 84" Safeset Reservoir, 2 Blood Sampling Port, 3ml Flush Device, Un-Bonded Macrodrip
Catalog Number
42801-28
Brand Name
ICU Medical
Version/Model Number
42801-28
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"
Yes
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
79a998df-8292-4838-b0f7-5a8f9d6c0113
Public Version Date
September 06, 2021
Public Version Number
1
DI Record Publish Date
August 29, 2021
Package DI Number
10887709120775
Quantity per Package
20
Contains DI Package
00887709120778
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 |