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MARS Monitor

FDA UDI

Class II (US FDA UDI)

by Gambro, Inc.

Identity

Trade Name
MARS Monitor FDA UDI
Generic Name
Bound solute dialysis system pump/monitor FDA UDI
Device Name
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. FDA UDI
Model / Reference
800437 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
800437 FDA UDI
Primary DI / UDI-DI
37332414106936 FDA UDI
FDA Product Code
FLD FDA UDI
KDI FDA UDI
GMDN Term
Bound solute dialysis system pump/monitor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5870 FDA UDI
876.5860 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Bound solute dialysis system pump/monitor

MARS Monitor by Gambro, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gambro, Inc.

Sources (1)

  • FDA UDI 75a31da4-0c99-4937-9f04-d400414c5163 36 fields · synced May 31, 2026