ACIST RXi® System and Accessories - RXi System Overpack, p/n 800981-003Contents: - ACIST MEDICAL SYSTEMS, INC.

Duns Number:926684994

Device Description: RXi System Overpack, p/n 800981-003Contents: Console, Power Supply, Bed Mount, USB Drive, RXi System Overpack, p/n 800981-003Contents: Console, Power Supply, Bed Mount, USB Drive, and Accessory Box (Cables)

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More Product Details

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

Product Characteristics

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 Details

Product Code

OBI

Product Code Name

Catheter, Pressure Monitoring, Cardiac

Device Record Status

Public Device Record Key

6dae65ed-a378-4299-b9fd-889199487046

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 09, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACIST MEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 193