Duns Number:926684994
Device Description: RXi System Overpack, p/n 800981-002Contents: Console, Power Supply, Bed Mount, USB Drive, RXi System Overpack, p/n 800981-002Contents: 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
Not in Commercial Distribution
Commercial Distribution End Date
January 23, 2017
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
d411eac0-e905-4818-971a-2c0f1fdaacae
Public Version Date
April 15, 2019
Public Version Number
4
DI Record Publish Date
October 13, 2016
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 |