Duns Number:878263359
Device Description: Alinity m Bottle for Ethanol Use
Catalog Number
09N20-012
Brand Name
Alinity m
Version/Model Number
09N20-012
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
LSL
Product Code Name
DNA-REAGENTS, NEISSERIA
Public Device Record Key
990bfb2d-8e26-45dc-baa6-bb3a371daf56
Public Version Date
May 26, 2022
Public Version Number
1
DI Record Publish Date
May 18, 2022
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 | 339 |
2 | A medical device with a moderate to high risk that requires special controls. | 76 |
3 | A medical device with high risk that requires premarket approval | 36 |