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Mars Treatment Kit

FDA UDI

Class II (US FDA UDI)

by Gambro, Inc.

Identity

Trade Name
Mars Treatment Kit FDA UDI
Generic Name
Bound solute dialysis system component set FDA UDI
Device Name
The MARS Treatment Kit type 1115/1-PrisMARS US is a set of disposable items to be used with the MARS Monitor 1TC for performing MARS therapy, with exclusive use being made of the MARS Monitor 1TC in combination with the Prisma Control Unit (produced by Gambro). FDA UDI
Model / Reference
800480 FDA UDI
Description
The MARS Treatment Kit type 1115/1-PrisMARS US is a set of disposable items to be used with the MARS Monitor 1TC for performing MARS therapy, with exclusive use being made of the MARS Monitor 1TC in combination with the Prisma Control Unit (produced by Gambro). FDA UDI

Identifiers

Catalog Number
800480 FDA UDI
Primary DI / UDI-DI
37332414106950 FDA UDI
510(k) Number
K113313 FDA UDI
FDA Product Code
FLD FDA UDI
GMDN Term
Bound solute dialysis system component set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5870 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Mars Treatment Kit 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 b2f70691-aba9-432a-9e9a-6fc4570aefe3 38 fields · synced Jun 6, 2026