Duns Number:118380146
Device Description: Transpac™ IT Bifurcated Monitoring Kit with Male/Male Bridge, 48", 2 03 ml Squeeze Flush D Transpac™ IT Bifurcated Monitoring Kit with Male/Male Bridge, 48", 2 03 ml Squeeze Flush Devices, Macrodrip, Disposable Transducer (Pole Mount) Un-Bonded
Catalog Number
42801-22
Brand Name
ICU Medical
Version/Model Number
42801-22
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
cf4f798d-372a-4a22-b1fd-f9443fb9df10
Public Version Date
February 02, 2022
Public Version Number
1
DI Record Publish Date
January 25, 2022
Package DI Number
10887709124506
Quantity per Package
10
Contains DI Package
00887709124509
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4887 |