Duns Number:079264306
Device Description: Baebies Extraction SolutionGeneral Purpose Reagent, For Laboratory Use
Catalog Number
3726
Brand Name
Baebies Extraction Solution
Version/Model Number
2114
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
1ae8a74a-4460-486c-a688-e92e871370cd
Public Version Date
January 14, 2019
Public Version Number
1
DI Record Publish Date
December 12, 2018
Package DI Number
10819704020293
Quantity per Package
12
Contains DI Package
00819704020296
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 |