Duns Number:122561087
Device Description: BD BACTEC™ MGIT™ 320 System
Catalog Number
441743
Brand Name
BD BACTEC™ MGIT™ 320 System
Version/Model Number
441743
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
K974883
Product Code
MDB
Product Code Name
SYSTEM, BLOOD CULTURING
Public Device Record Key
5b5eba16-9c8f-47f3-83c9-7cf639128b64
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
May 25, 2018
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 |