Duns Number:079375431
Device Description: HALYARD* MIC-KEY* Bolus Extension Set 0123-12
Catalog Number
0123-12
Brand Name
Halyard
Version/Model Number
94933
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
K993138,K993138
Product Code
KNT
Product Code Name
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Public Device Record Key
a4fc8768-da9d-4da8-97a3-2ff24f14e6f8
Public Version Date
April 20, 2020
Public Version Number
6
DI Record Publish Date
March 15, 2017
Package DI Number
30680651949333
Quantity per Package
5
Contains DI Package
10680651949339
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 |