Duns Number:122561087
Device Description: BD BBL™ Sensi-Disc™ Clarithromycin - 15 µg
Catalog Number
231678
Brand Name
BD BBL™ Sensi-Disc™ Clarithromycin - 15 µg
Version/Model Number
231678
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
-
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
K920131,K920131
Product Code
JTN
Product Code Name
SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL
Public Device Record Key
96ecc92e-ff53-4270-9152-86e15f173809
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 03, 2016
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 | 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 |