Duns Number:122561087
Device Description: BD BACTEC™ Standard/10 Aerobic/F Culture Vials (plastic)
Catalog Number
442027
Brand Name
BD BACTEC™ Standard/10 Aerobic/F Culture Vials (plastic)
Version/Model Number
442027
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)
Yes
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
K161810,K161810
Product Code
MDB
Product Code Name
SYSTEM, BLOOD CULTURING
Public Device Record Key
c997e583-f6e3-48ff-90ab-d895978d1175
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
May 25, 2018
Package DI Number
30382904420278
Quantity per Package
50
Contains DI Package
00382904420277
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 |