Duns Number:086785110
Device Description: The Adapter Insert is used with The BacT/ALERT Blood Collection Adapter. It can be locked The Adapter Insert is used with The BacT/ALERT Blood Collection Adapter. It can be locked inside the Adapter Cap to allow blood to be filled into vacuum collection tubes.
Catalog Number
-
Brand Name
BacT/ALERT® Blood Collection Adapter Insert
Version/Model Number
BacT/ALERT® Blood Collection Adapter Insert
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 26, 2021
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
K933939,K933939,K933939
Product Code
GIM
Product Code Name
Tubes, Vacuum Sample, With Anticoagulant
Public Device Record Key
a44a7cae-5160-41ca-8b4e-25663091ba72
Public Version Date
March 23, 2021
Public Version Number
5
DI Record Publish Date
December 14, 2016
Package DI Number
03573026125769
Quantity per Package
1
Contains DI Package
03573026556129
Package Discontinue Date
February 26, 2021
Package Status
Not 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 |