Duns Number:068199363
Device Description: FiberFlo Capsule Filters
Catalog Number
LI050A
Brand Name
FiberFlo
Version/Model Number
93250-000
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K983126,K983126
Product Code
FIP
Product Code Name
Subsystem, Water Purification
Public Device Record Key
418e3ed9-1c9c-4678-a5fe-107b246e9e93
Public Version Date
August 30, 2022
Public Version Number
6
DI Record Publish Date
November 30, 2017
Package DI Number
30677964031190
Quantity per Package
6
Contains DI Package
00677964031199
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2999 |
2 | A medical device with a moderate to high risk that requires special controls. | 362 |