Duns Number:079264306
Device Description: 4-MU Dilution SetGeneral Purpose Reagent, For Laboratory Use.
Catalog Number
3952
Brand Name
Baebies 4-MU Dilution Set
Version/Model Number
3952
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PPM
Product Code Name
General Purpose Reagent
Public Device Record Key
51e49b93-939f-40e3-811c-10b4d0d34fa7
Public Version Date
November 05, 2018
Public Version Number
1
DI Record Publish Date
October 04, 2018
Package DI Number
10819704020316
Quantity per Package
12
Contains DI Package
00819704020319
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |