DEVICE: MARS Monitor (37332414106936)
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Device Identifier (DI) Information
MARS Monitor
800437
In Commercial Distribution
800437
GAMBRO AB
800437
In Commercial Distribution
800437
GAMBRO AB
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.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
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| Yes | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 46214 | Bound solute dialysis system pump/monitor |
A mains electricity (AC-powered) device that is a component of a bound solute dialysis system and used to control the circulation of a high-concentration albumin dialysate through a filter, to bind and remove albumin-bound toxins (e.g., bile acids, bilirubin, heavy metals, phenols) from a patient's blood during extracorporeal blood purification, typically in persons suffering liver failure or poisoning/drug overdose. It uses a dedicated set of filters, tubing, and connectors and may be controlled by dedicated application software.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| FLD | Apparatus, Hemoperfusion, Sorbent |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature: between -4 and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify: Atmospheric Air Pressure between 500 and 1060 millibar, Relative Humidity is non-condensing. |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
75a31da4-0c99-4937-9f04-d400414c5163
March 29, 2018
2
June 08, 2015
March 29, 2018
2
June 08, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)933-0303
medinfo_medproducts@baxter.com
medinfo_medproducts@baxter.com