Catalog Number

1584

Brand Name

HUDSON RCI

Version/Model Number

IPN042629

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K945359,K945359

Product Code

BYD

Product Code Name

CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

Public Device Record Key

2ad29e6f-488c-4a8d-b25b-32f7e4afceaf

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

44026704399176

Quantity per Package

30

Contains DI Package

04026704399178

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case