Catalog Number

HME-01F

Brand Name

HME

Version/Model Number

HME-01F

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

7414f5b9-8d3d-46f9-8d1e-cf757d99e130

Public Version Date

October 12, 2021

Public Version Number

2

DI Record Publish Date

April 17, 2020

Package DI Number

10850014574410

Quantity per Package

50

Contains DI Package

00850014574444

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box