Duns Number:068199363
Catalog Number
-
Brand Name
Actril Residual Test Strips
Version/Model Number
78258-000
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K861730,K861730
Product Code
FKQ
Product Code Name
System, Dialysate Delivery, Central Multiple Patient
Public Device Record Key
0dc5ff56-d073-4b55-98fd-6a6869e28663
Public Version Date
April 27, 2022
Public Version Number
5
DI Record Publish Date
July 09, 2018
Package DI Number
30677964008253
Quantity per Package
100
Contains DI Package
40677964023987
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 | 2999 |
2 | A medical device with a moderate to high risk that requires special controls. | 362 |