Duns Number:354021099
Device Description: The MARS Treatment Kit type 1115/1-PrisMARS US is a set of disposable items to be used wit 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).
Catalog Number
800480
Brand Name
Mars Treatment Kit
Version/Model Number
800480
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 30, 2015
Issuing Agency
In GS1
MRI safety Status
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K113313
Product Code
FLD
Product Code Name
Apparatus, Hemoperfusion, Sorbent
Public Device Record Key
b2f70691-aba9-432a-9e9a-6fc4570aefe3
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 08, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |