Catalog Number

370

Brand Name

Busse Hospital Disposables

Version/Model Number

370

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K940720,K940720,K940720

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

778c93f0-ebfb-4bb7-8026-827c4b8d5599

Public Version Date

May 06, 2020

Public Version Number

4

DI Record Publish Date

September 01, 2016

Package DI Number

10849233000923

Quantity per Package

100

Contains DI Package

00849233000926

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-