Duns Number:080728314
Device Description: Care Orchestrator Essence, Clinical data collection management information system applicat Care Orchestrator Essence, Clinical data collection management information system application software
Catalog Number
1135709
Brand Name
Care Orchestrator Essence Software
Version/Model Number
3.3
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BZD
Product Code Name
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Public Device Record Key
592f6d30-d938-4f8f-8661-bda356f2b815
Public Version Date
February 01, 2021
Public Version Number
1
DI Record Publish Date
January 22, 2021
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 | 151 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3279 |