Catalog Number

-

Brand Name

Refurbished BodyGuard® 575 ColorVision® Pump System

Version/Model Number

100-615PXCVR

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 20, 2020

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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

K042696

Product Code

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

09090793-fb8d-4557-b624-0d6c13f1ef50

Public Version Date

July 04, 2022

Public Version Number

6

DI Record Publish Date

September 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-