Duns Number:086785110
Device Description: BacT/ALERT Worksafe Collection Kit contains most of the items to facilitate blood culture BacT/ALERT Worksafe Collection Kit contains most of the items to facilitate blood culture collection. This kit contains FA Plus Pediatric Bottle.
Catalog Number
-
Brand Name
Worksafe™ Blood Culture Collection Kits: FAN®PLUS Pediatric
Version/Model Number
Worksafe™ Blood Culture Collection Kits: FAN®PLUS Pediatric
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
-
Product Code
OIB
Product Code Name
Blood and urine collection kit (excludes HIV testing)
Public Device Record Key
36d0246f-2720-45ad-87e0-68b3024aa300
Public Version Date
May 13, 2022
Public Version Number
2
DI Record Publish Date
April 23, 2020
Package DI Number
03573026601898
Quantity per Package
20
Contains DI Package
03573026606480
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 |