Duns Number:079264306
Device Description: 4-MU IDS Reagent Tube, 4.3mLAnalyte Specific Reagent - Analytical and performance characte 4-MU IDS Reagent Tube, 4.3mLAnalyte Specific Reagent - Analytical and performance characteristics are not established.
Catalog Number
3951
Brand Name
Baebies 4-MU IDS
Version/Model Number
3640
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
MVU
Product Code Name
Reagents, Specific, Analyte
Public Device Record Key
c33ae330-f0b1-41e3-a14c-3cce6573ee0f
Public Version Date
November 05, 2018
Public Version Number
1
DI Record Publish Date
October 04, 2018
Package DI Number
10819704020309
Quantity per Package
12
Contains DI Package
00819704020302
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 |