Duns Number:122561087
Device Description: BD BBL™ CHROMagar® MRSA II 100mm (20 each)
Catalog Number
215228
Brand Name
BD BBL™ CHROMagar® MRSA II
Version/Model Number
215228
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
K092767,K092767,K092767
Product Code
JSO
Product Code Name
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON AGAR
Public Device Record Key
046169f2-f966-48e6-9426-cf8f8eb21d29
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 23, 2016
Package DI Number
30382902152287
Quantity per Package
2
Contains DI Package
10382902152283
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 |