Duns Number:595138793
Device Description: IN-LINE INJECTATE SENSOR CABLE with cable length 90" . It does not has a connector for the IN-LINE INJECTATE SENSOR CABLE with cable length 90" . It does not has a connector for the monitor.
Catalog Number
684063
Brand Name
IN-LINE INJECTATE SENSOR CABLE-SP4046
Version/Model Number
684063
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
DQO
Product Code Name
Catheter, Intravascular, Diagnostic
Public Device Record Key
dad6512a-78ac-4619-a26c-3cb0991cb56a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 25, 2016
Package DI Number
50886333640633
Quantity per Package
1
Contains DI Package
00886333640638
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Zip bag
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 392 |