Duns Number:086785110
Device Description: BACT/ALERT® PF Culture Bottles are used in qualitative procedures for recovery and detecti BACT/ALERT® PF Culture Bottles are used in qualitative procedures for recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood
Catalog Number
-
Brand Name
BACT/ALERT® PF
Version/Model Number
BACT/ALERT® PF
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
K020923,K020923,K020923
Product Code
MDB
Product Code Name
System, blood culturing
Public Device Record Key
84b433e8-843e-4d2c-993d-144f2b40488d
Public Version Date
April 30, 2020
Public Version Number
1
DI Record Publish Date
April 22, 2020
Package DI Number
03573026055851
Quantity per Package
2
Contains DI Package
03573026611835
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |