Duns Number:122561087
Device Description: BD BBL™ Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX™) // Modified Thayer- BD BBL™ Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX™) // Modified Thayer-Martin (MTM II) Agar
Catalog Number
221623
Brand Name
BD BBL™ Chocolate II Agar/Modified Thayer-Martin Agar
Version/Model Number
221623
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
K760588,K760588,K760588
Product Code
JTY
Product Code Name
CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
Public Device Record Key
516305c8-84cb-4e00-b116-baf4ce48b6b4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 21, 2016
Package DI Number
30382902216231
Quantity per Package
2
Contains DI Package
10382902216237
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 |