Duns Number:057827420
Device Description: Bacerial Detection System for Quality Control Testing of Platelet Products
Catalog Number
-
Brand Name
Haemonetics
Version/Model Number
400-03
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
BK070063,BK070063
Product Code
MZC
Product Code Name
System,detection,bacterial, for platelet transfusion products
Public Device Record Key
1c3a9194-bee8-4d3b-a81f-cc4140caf044
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
March 20, 2017
Package DI Number
30887691306373
Quantity per Package
10
Contains DI Package
20887691306376
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 158 |
| U | Unclassified | 2 |