Duns Number:151507563
Device Description: High pressure braided swivel line set
Catalog Number
-
Brand Name
Procedure Products Lines
Version/Model Number
B72-R072
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
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
K914128,K914128
Product Code
DQO
Product Code Name
Catheter, Intravascular, Diagnostic
Public Device Record Key
e2c16a69-afca-4871-8eda-8e567dc033d8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 03, 2017
Package DI Number
B160B72R0722
Quantity per Package
25
Contains DI Package
B160B72R0721
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 | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 98 |