Duns Number:015623119
Catalog Number
ONEL028-01
Brand Name
Halyard
Version/Model Number
ONEL028-01_0007
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
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
-
Product Code
NNI
Product Code Name
CONTAINER, SPECIMEN, NON-STERILE
Public Device Record Key
703fcf45-603c-4fe4-8da3-ae0ffdfa8d4b
Public Version Date
October 29, 2021
Public Version Number
2
DI Record Publish Date
December 11, 2020
Package DI Number
20809160321109
Quantity per Package
100
Contains DI Package
10809160321102
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 | 5180 |
2 | A medical device with a moderate to high risk that requires special controls. | 28744 |