Duns Number:080728314
Device Description: Care Orchestrator, Medical equipment clinical data interfacing software
Catalog Number
1126366
Brand Name
Care Orchestrator
Version/Model Number
1.22
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
-
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
e2ba3552-6033-4b93-baa0-88265945073f
Public Version Date
June 27, 2019
Public Version Number
1
DI Record Publish Date
June 19, 2019
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 |