Duns Number:094651270
Device Description: CONTINUOUS FLUSH DEVICE, 3CC/HR FLOW RATE, Y-CONFIGURATION, BLUE W/TAB
Catalog Number
100-205
Brand Name
DELTA-FLOW
Version/Model Number
Y-Configuration
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"
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
K780479,K780479
Product Code
KRA
Product Code Name
Catheter, Continuous Flush
Public Device Record Key
a68c04ad-3b44-473c-a345-056bfb587a2f
Public Version Date
December 18, 2019
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
H6711002051
Quantity per Package
50
Contains DI Package
H6711002050
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 | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 274 |