Duns Number:388240673
Device Description: Washing Solution is used for cleaning the Siemens Healthcare Diagnostics coagulation analy Washing Solution is used for cleaning the Siemens Healthcare Diagnostics coagulation analyzers
Catalog Number
OWZC39
Brand Name
Washing Solution for Coagulation Analyzers
Version/Model Number
10446684
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
K924124,K924124
Product Code
JPA
Product Code Name
SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
Public Device Record Key
0334be5e-4e7e-4ce4-89b8-ee38df2c9c7c
Public Version Date
November 18, 2021
Public Version Number
5
DI Record Publish Date
September 24, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |