AccessGUDID - DEVICE: Mars Treatment Kit (37332414106950)

GUDID

Device Identifier (DI) Information

Brand Name: Mars Treatment Kit
Version or Model: 800480
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 800480
Company Name: GAMBRO AB

Primary DI Number: 37332414106950
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2015
Device Count: 1
Labeler D-U-N-S® Number*: 354021099 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLD	Apparatus, Hemoperfusion, Sorbent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113313	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: 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 Temperature: between 8 and 27 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b2f70691-aba9-432a-9e9a-6fc4570aefe3
Public Version Date: July 27, 2023
Public Version Number: 4
DI Record Publish Date: June 08, 2015