Duns Number:368457563
Device Description: Cardiac output in-line injectate probe for GE monitors, Edwards CO set, 0.9 m/3 ft
Catalog Number
9446-910
Brand Name
Vital Signs™
Version/Model Number
9446-910
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"
Yes
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
DQE
Product Code Name
Catheter, Oximeter, Fiber-Optic
Public Device Record Key
45012561-3851-46c3-b50e-658c81097ec1
Public Version Date
December 24, 2018
Public Version Number
1
DI Record Publish Date
November 23, 2018
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 | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 600 |