Duns Number:120664557
Device Description: The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and e The TQE PlusEndotoxinFilter(Flat)is a hollow fiber ultrafilter that retains bacteria and endotoxin from fluid.
Catalog Number
-
Brand Name
TQE Plus Endotoxin 10" Filter Flat 222 Head
Version/Model Number
TQE0.005-10P3E
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
K161304,K161304,K161304
Product Code
FIP
Product Code Name
Subsystem, Water Purification
Public Device Record Key
fbeb2ecb-ae47-4bcd-b198-062e1cd527b6
Public Version Date
August 24, 2020
Public Version Number
5
DI Record Publish Date
December 21, 2017
Package DI Number
10868277000416
Quantity per Package
1
Contains DI Package
00868277000419
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
1 part per box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |