Duns Number:122561087
Device Description: BD BBL™ TB Decolorizer
Catalog Number
212517
Brand Name
BD BBL™ TB Decolorizer
Version/Model Number
212517
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
LED
Product Code Name
STAINS, CHEMICAL SOLUTION
Public Device Record Key
f2798293-b0e4-47a0-a448-cd7582d603d2
Public Version Date
March 11, 2019
Public Version Number
2
DI Record Publish Date
May 25, 2018
Package DI Number
30382902125175
Quantity per Package
4
Contains DI Package
00382902125174
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelfpack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 611 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 614 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |