Duns Number:926684994
Device Description: RXi System Overpack, p/n 800981-004Contents: Console, Power Supply, Bed Mount, USB Drive, RXi System Overpack, p/n 800981-004Contents: Console, Power Supply, Bed Mount, USB Drive, and Accessory Box (Cables)
Catalog Number
-
Brand Name
ACIST RXi® System and Accessories
Version/Model Number
014666
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
-
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
K132474
Product Code
OBI
Product Code Name
Catheter, Pressure Monitoring, Cardiac
Public Device Record Key
f6ebf01a-59d2-4042-8ef4-90b16e372c7b
Public Version Date
September 03, 2018
Public Version Number
1
DI Record Publish Date
August 02, 2018
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. | 193 |