Duns Number:388240673
Device Description: The N-cuvettessegment is an consumable in the BNII system.
Catalog Number
OVIB31
Brand Name
N Cuvette Segments for BN II
Version/Model Number
10446520
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K943997,K943997
Product Code
DEW
Product Code Name
IGG, ANTIGEN, ANTISERUM, CONTROL
Public Device Record Key
19aa22c2-7673-4225-b00c-ca1d82736de4
Public Version Date
September 16, 2022
Public Version Number
5
DI Record Publish Date
November 15, 2017
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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |