Duns Number:091381780
Device Description: Reagent test strips used to test for the presence of blood in dialysate fluid during the h Reagent test strips used to test for the presence of blood in dialysate fluid during the hemodialysis procedure.
Catalog Number
812145
Brand Name
SteriChek® Blood Leak Reagent Strips
Version/Model Number
812014
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
K042322,K042322,K042322
Product Code
FJD
Product Code Name
Detector, Leak, Blood
Public Device Record Key
99ff205b-df4a-4d56-aaec-96150a9ec45a
Public Version Date
September 12, 2018
Public Version Number
4
DI Record Publish Date
October 28, 2016
Package DI Number
00851575007129
Quantity per Package
324
Contains DI Package
00851575007112
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |