Catalog Number

BV4000

Brand Name

BEAR

Version/Model Number

BV4000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

-

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

K981751

Product Code

EOB

Product Code Name

Nasopharyngoscope (Flexible Or Rigid)

Public Device Record Key

e04e4153-d501-489b-af0e-947ef3c19877

Public Version Date

April 04, 2022

Public Version Number

3

DI Record Publish Date

March 03, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-