Catalog Number

0570-0374

Brand Name

GlideScope®

Version/Model Number

BFlex™ 5.0

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"

-

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

K183256,K183256

Product Code

EOQ

Product Code Name

Bronchoscope (Flexible Or Rigid)

Public Device Record Key

cbf3e488-aed0-46c9-a1ca-fbf26b317eae

Public Version Date

August 09, 2019

Public Version Number

1

DI Record Publish Date

August 01, 2019

Package DI Number

10879123006339

Quantity per Package

5

Contains DI Package

00879123006332

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-