Duns Number:032528935
Device Description: 1 1/2” Dual Bank, Big Blue Filter Assembly with By-Pass Valves, Gauges and Sample Ports, D 1 1/2” Dual Bank, Big Blue Filter Assembly with By-Pass Valves, Gauges and Sample Ports, Digital
Catalog Number
-
Brand Name
Dual Big Blue Sediment Filter
Version/Model Number
K-A-PT-5054-D
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
FIP
Product Code Name
Subsystem, Water Purification
Public Device Record Key
6d90f4a2-4b3f-40fb-ac85-70ef860e4fb5
Public Version Date
July 22, 2021
Public Version Number
1
DI Record Publish Date
July 14, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 264 |