Mars Treatment Kit

Basic Information

• Brand Name: Mars Treatment Kit
• Primary DI: 37332414106950
• Version / Model: 800480
• Catalog Number: 800480
• Company Name: GAMBRO AB
• Labeler DUNS: 354021099
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-06-08
• Public Version: 4
• Public Version Date: 2023-07-27
• Public Version Status: Update
• Public Device Record Key: b2f70691-aba9-432a-9e9a-6fc4570aefe3
• Distribution End Date: 2015-06-30

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).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FLD	Apparatus, Hemoperfusion, Sorbent	Gastroenterology, Urology	876.5870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46212	Bound solute dialysis system component set	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	37332414106950	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K113313	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from direct sunlight, water, and moisture. Do not store or transport at temperatures below freezing, since this might lead to mechanical damage.
• Type: Storage Environment Temperature
• Temperature Range: 8 – 27 Degrees Celsius