Duns Number:017246562
Catalog Number
-
Brand Name
Centurion
Version/Model Number
CVAHG001
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
Yes
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
DRS
Product Code Name
TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
Public Device Record Key
84bb1ff3-ae08-4524-b72d-54a7c5b6ce53
Public Version Date
June 11, 2018
Public Version Number
3
DI Record Publish Date
September 07, 2016
Package DI Number
00653160288360
Quantity per Package
10
Contains DI Package
20653160288364
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 6043 |
2 | A medical device with a moderate to high risk that requires special controls. | 4077 |
U | Unclassified | 1 |