Catalog Number

41172

Brand Name

HUDSON RCI

Version/Model Number

IPN044403

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

-

Product Code

BYD

Product Code Name

CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

Public Device Record Key

558188af-d2f6-42b9-b3c0-4e7256ddd067

Public Version Date

October 16, 2018

Public Version Number

1

DI Record Publish Date

September 15, 2018

Package DI Number

24026704389876

Quantity per Package

6

Contains DI Package

04026704389872

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box