Duns Number:480868538
Device Description: The ARGUS® PB-2000 parameter box is acquiring and monitoring patient’s vital parameters su The ARGUS® PB-2000 parameter box is acquiring and monitoring patient’s vital parameters such as invasive blood pressure (IBP), temperature, CO2, and SpO2. All vital parameters and evaluations are registered and calculated in the ARGUS® PB-2000. This data is then transmitted to the visualization unit via a serial interface.
Catalog Number
-
Brand Name
ARGUS® PB-2000
Version/Model Number
3.920983
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
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
K012226
Product Code
MHX
Product Code Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Public Device Record Key
1e60e342-58d4-4180-a47f-e77152bc65b4
Public Version Date
February 10, 2020
Public Version Number
3
DI Record Publish Date
September 18, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 93 |