Duns Number:079375431
Device Description: MIC-KEY* SF Single Port Extension Set with ENFit® Connector, Secure Flow Right Angle Conne MIC-KEY* SF Single Port Extension Set with ENFit® Connector, Secure Flow Right Angle Connector, ENFit® Connector and Clamp, 30 cm
Catalog Number
7144-12
Brand Name
Halyard
Version/Model Number
47084
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KNT
Product Code Name
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Public Device Record Key
685020a6-6cc8-4362-b68d-ba158ac2f12c
Public Version Date
October 07, 2019
Public Version Number
4
DI Record Publish Date
May 20, 2018
Package DI Number
30680651470844
Quantity per Package
5
Contains DI Package
20680651470847
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 269 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5221 |