Catalog Number

-

Brand Name

BodyGuard® Microset with Filter

Version/Model Number

A120-112XSFK

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 04, 2019

Issuing Agency

In HIBCC

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"

Yes

For Single-Use

Yes

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,K042696

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

fc002cf0-080b-4b36-a7be-d350588a639f

Public Version Date

July 09, 2020

Public Version Number

4

DI Record Publish Date

July 27, 2016

Package DI Number

B101A120112XSFK1

Quantity per Package

16

Contains DI Package

B101A120112XSFK0

Package Discontinue Date

November 04, 2019

Package Status

Not in Commercial Distribution

Package Type

Case