Duns Number:120818216
Device Description: 10" WINGED SAFETY INFUSION SET W/22 GA. X 1.0" HUBER NEEDLE AND NEEDLELESS Y-SITE
Catalog Number
BHY-2250
Brand Name
Churchill Medical Systems
Version/Model Number
BHY-2250
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
K020544,K020544
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
94064d86-25f9-4e5a-86d5-4c3ac759528c
Public Version Date
July 31, 2020
Public Version Number
2
DI Record Publish Date
April 21, 2020
Package DI Number
38498840010380
Quantity per Package
12
Contains DI Package
08498840010389
Package Discontinue Date
July 31, 2020
Package Status
Not 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 | 124 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 833 |