Duns Number:079375431
Device Description: HALYARD* MIC-KEY* Continuous Feed Extension Set 0122-02
Catalog Number
0122-02
Brand Name
Halyard
Version/Model Number
94932
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K982894,K982894
Product Code
KNT
Product Code Name
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Public Device Record Key
b956df9c-bce6-4d0c-8457-e94827f50534
Public Version Date
April 20, 2020
Public Version Number
6
DI Record Publish Date
March 15, 2017
Package DI Number
30680651949326
Quantity per Package
5
Contains DI Package
10680651949322
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |