Mars Treatment Kit 800480

GUDID 37332414106950

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 exc

GAMBRO AB

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Primary Device ID37332414106950
NIH Device Record Keyb2f70691-aba9-432a-9e9a-6fc4570aefe3
Commercial Distribution Discontinuation2015-06-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMars Treatment Kit
Version Model Number800480
Catalog Number800480
Company DUNS354021099
Company NameGAMBRO AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep 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 TemperatureBetween 8 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep 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 TemperatureBetween 8 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep 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 TemperatureBetween 8 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep 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 TemperatureBetween 8 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep 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 TemperatureBetween 8 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep 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 TemperatureBetween 8 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep 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 TemperatureBetween 8 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep 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 TemperatureBetween 8 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep 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 TemperatureBetween 8 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep 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 TemperatureBetween 8 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep 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 TemperatureBetween 8 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep 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 TemperatureBetween 8 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep 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 TemperatureBetween 8 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep 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 TemperatureBetween 8 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep 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 TemperatureBetween 8 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep 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 TemperatureBetween 8 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep 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 TemperatureBetween 8 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS137332414106950 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLDApparatus, Hemoperfusion, Sorbent

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-06-08

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