Duns Number:079375431
Device Description: MIC-KEY* Single Port Feed Extension Set with ENFit® Connector, SECUR-LOK* Right Angle Conn MIC-KEY* Single Port Feed Extension Set with ENFit® Connector, SECUR-LOK* Right Angle Connector and Bolus ENFit® Connector and Clamp, 30 cm
Catalog Number
0144-12-200
Brand Name
Halyard
Version/Model Number
47319
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
K993138,K993138,K993138
Product Code
KNT
Product Code Name
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Public Device Record Key
d93f1235-808b-42a8-b53a-81f23f3b06d2
Public Version Date
April 20, 2020
Public Version Number
5
DI Record Publish Date
April 09, 2018
Package DI Number
30680651473197
Quantity per Package
50
Contains DI Package
20680651473190
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 |