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Mars Treatment Kit Type 1116/1 - X-Mars Us

FDA UDI

Class II (US FDA UDI)

by Gambro, Inc.

Identity

Trade Name
MARS TREATMENT KIT TYPE 1116/1 - X-MARS US FDA UDI
Generic Name
Bound solute dialysis system component set FDA UDI
Device Name
The MARS Treatment Kit Type 1116/1 X-MARS is a set of disposable items to be used with the MARS Monitor 1TC in combination with the Prismaflex device (produced by Gambro Lundia AB) for MARS therapy. FDA UDI
Model / Reference
800541 FDA UDI
Description
The MARS Treatment Kit Type 1116/1 X-MARS is a set of disposable items to be used with the MARS Monitor 1TC in combination with the Prismaflex device (produced by Gambro Lundia AB) for MARS therapy. FDA UDI

Identifiers

Catalog Number
800541 FDA UDI
Primary DI / UDI-DI
37332414107728 FDA UDI
510(k) Number
K133807 FDA UDI
FDA Product Code
FLD FDA UDI
KDI 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
876.5860 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Bound solute dialysis system component set

Mars Treatment Kit Type 1116/1 - X-Mars Us 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 e1a492a7-ec05-46d4-8bd0-edd1f9f54f59 37 fields · synced May 30, 2026