Duns Number:392994778
Device Description: Exchange transfusion set
Catalog Number
275.00
Brand Name
VYGON
Version/Model Number
275.00
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BRZ
Product Code Name
Set, blood transfusion
Public Device Record Key
5c9c8751-8e46-494f-a498-a97976c6fd52
Public Version Date
October 16, 2019
Public Version Number
2
DI Record Publish Date
June 26, 2019
Package DI Number
53660812106127
Quantity per Package
8
Contains DI Package
13660812106129
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 195 |