Duns Number:308667539
Device Description: S4987 Crea Rinse Solution II 600mL for ABL8XX, USA
Catalog Number
944-155
Brand Name
Rinse Solution II S4987 REF 944-155 600mL
Version/Model Number
944-155
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CEM
Product Code Name
ELECTRODE, ION SPECIFIC, POTASSIUM
Public Device Record Key
09e8072e-3b97-4cf0-8fd8-f37472c78e10
Public Version Date
October 22, 2018
Public Version Number
1
DI Record Publish Date
September 21, 2018
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 | 124 |
2 | A medical device with a moderate to high risk that requires special controls. | 66 |