Duns Number:125006353
Device Description: Advanced Instruments cuvettes are used to facilitate sample management while using Advance Advanced Instruments cuvettes are used to facilitate sample management while using Advanced Instruments osmometers
Catalog Number
200220
Brand Name
Advanced Instruments Cuvettes
Version/Model Number
200220
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
-
Product Code
JJM
Product Code Name
Osmometer For Clinical Use
Public Device Record Key
ac3da7cf-9949-4887-8ea0-7d22a7dc3299
Public Version Date
November 19, 2020
Public Version Number
2
DI Record Publish Date
September 21, 2020
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 | 50 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |