Duns Number:790888833
Device Description: An electro-mechanical carousel instrument that provides movement and placement of blood pl An electro-mechanical carousel instrument that provides movement and placement of blood plasma specimens to ensure the proper counting sequence for a blood volume test.
Catalog Number
-
Brand Name
BVA100
Version/Model Number
SC25 MK2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LXG
Product Code Name
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Public Device Record Key
e2484550-3ad8-4662-a4a2-f3c37cd19748
Public Version Date
September 03, 2018
Public Version Number
1
DI Record Publish Date
August 01, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |