Catalog Number

-

Brand Name

BG545 with EPI28A

Version/Model Number

100-743XI

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 21, 2017

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

05228413-dcf8-4193-b02b-32f2dffc7256

Public Version Date

July 04, 2022

Public Version Number

5

DI Record Publish Date

September 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-