Catalog Number

-

Brand Name

Standard HME

Version/Model Number

6200/51BAUA069/0001

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

BYD

Product Code Name

Condenser, Heat And Moisture (Artificial Nose)

Public Device Record Key

b9b87f9e-67c7-496a-bfc3-4c552818bcf3

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

25060120952589

Quantity per Package

50

Contains DI Package

15060120952582

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box