Duns Number:354021099
Device Description: The MARS Treatment Kit Type 1116/1 X-MARS is a set of disposable items to be used with the The MARS Treatment Kit Type 1116/1 X-MARS is a set of disposable items to be used with the MARS Monitor 1TC in combination with the Prismaflex device (produced by Gambro Lundia AB) for MARS therapy.
Catalog Number
800541
Brand Name
MARS TREATMENT KIT TYPE 1116/1 - X-MARS US
Version/Model Number
800541
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
-
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
K133807
Product Code
FLD
Product Code Name
Apparatus, Hemoperfusion, Sorbent
Public Device Record Key
e1a492a7-ec05-46d4-8bd0-edd1f9f54f59
Public Version Date
October 11, 2022
Public Version Number
6
DI Record Publish Date
October 26, 2017
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 |