Duns Number:105505866
Device Description: An EMR system used in high acuity areas of the hospital (OR, ICU, Preop, PACU). A patient An EMR system used in high acuity areas of the hospital (OR, ICU, Preop, PACU). A patient record is populated with information such as healthcare professionals, medical devices, and HIS/lab systems.
Catalog Number
-
Brand Name
Picis Perioperative and Critical Care
Version/Model Number
8.6
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NSX
Product Code Name
Software, Transmission And Storage, Patient Data
Public Device Record Key
d5d1aa27-40bf-4488-a0d3-8a1df2a35f62
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 14, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |
| U | Unclassified | 3 |