Duns Number:354021099
Device Description: The MARS Monitor is a mechanical detoxification device used in conjunction with a renal re The MARS Monitor is a mechanical detoxification device used in conjunction with a renal replacement therapy system (companion device) for the removal of dialyzable (unbound) toxins, which are either water-soluble or, in the bound form, associated with serum albumin.
Catalog Number
800437
Brand Name
MARS Monitor
Version/Model Number
800437
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
FLD
Product Code Name
Apparatus, Hemoperfusion, Sorbent
Public Device Record Key
75a31da4-0c99-4937-9f04-d400414c5163
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 08, 2015
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |