FDA.reportPublic FDA data

Mars Treatment Kit

Primary DI
37332414106950
Brand
Mars Treatment Kit
Company
GAMBRO AB
Model
800480
Catalog number
800480
Device 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).
Published
2015-06-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLDApparatus, Hemoperfusion, Sorbent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLDApparatus, Hemoperfusion, SorbentGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113313000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113313000MOLECULAR ADSORBENT RECIRCULATING(MARS)Gambro Renal Products, Inc.2012-12-14FLD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37332414106950PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3733241410695037332414106950

GMDN Terms#

Term, Definition table
TermDefinition
Bound solute dialysis system component setA collection of devices that typically include filters, tubing, and connectors used in a bound solute dialysis system for the removal of 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. The items in this set are devices that function in association with a system pump/monitor. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from direct sunlight, water, and moisture. Do not store or transport at temperatures below freezing, since this might lead to mechanical damage.
Storage Environment Temperature8 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)933-0303Medinfo_medproducts@baxter.com

Regulatory Flags#

DUNS number
354021099
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332414124519AK 989556079556072021-03-22
07332414126766PRISMAFLEX7.219557922019-02-28
07332414105266Prismaflex5.XX1130812015-10-17
37332414127214CLCA - CLEANCART A9558509558502023-12-01
37332414127221CLCC - CLEANCART C9558519558512023-12-01
37332414107728MARS TREATMENT KIT TYPE 1116/1 - X-MARS US8005418005412017-10-26
07332414117702Prismaflex7.XX1152692015-10-09
07332414124236Prismaflex7.209555422017-11-24
37332414088317BiCart7201097332015-09-24
37332414110575BiCart12501140142015-09-24
37332414106936MARS Monitor 8004378004372015-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
37332414107728MARS TREATMENT KIT TYPE 1116/1 - X-MARS USGAMBRO ABFLD2017-10-26
07332414015473Adsorba Hemoperfusion cartridgeGambro Dialysatoren GmbHFLD2016-09-24
07332414015480Adsorba Hemoperfusion cartridgeGambro Dialysatoren GmbHFLD2016-09-24
37332414015474Adsorba Hemoperfusion cartridgeGambro Dialysatoren GmbHFLD2016-09-24
37332414015481Adsorba Hemoperfusion cartridgeGambro Dialysatoren GmbHFLD2016-09-24
37332414106936MARS Monitor GAMBRO ABFLD2015-06-08