Duns Number:122561087
Device Description: BD BBL™ Enterococcus Screen Agar QUAD Plate with Streptomycin/Gentamicin/Vancomycin
Catalog Number
222201
Brand Name
BD BBL™ Enterococcus Screen Agar QUAD Plate
Version/Model Number
222201
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
K951539,K951539,K951539
Product Code
JWY
Product Code Name
Manual antimicrobial susceptibility test systems
Public Device Record Key
abd01218-3000-499a-99bf-96cabbff2ac7
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 21, 2016
Package DI Number
30382902222010
Quantity per Package
1
Contains DI Package
10382902222016
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 |