Duns Number:122561087
Device Description: BD BACTEC™ Standard/10 Aerobic/F Culture Vials
Catalog Number
442260
Brand Name
BD BACTEC™ Standard/10 Aerobic/F Culture Vials
Version/Model Number
442260
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
K954921,K954921
Product Code
MDB
Product Code Name
SYSTEM, BLOOD CULTURING
Public Device Record Key
2ffab1dc-fa65-4c8a-adbb-6924d55a1b20
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
May 25, 2018
Package DI Number
30382904422609
Quantity per Package
50
Contains DI Package
00382904422608
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 |