Catalog Number

1065

Brand Name

HUDSON RCI

Version/Model Number

IPN041278

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

CBH

Product Code Name

DEVICE, FIXATION, TRACHEAL TUBE

Public Device Record Key

afecb822-cb49-44d7-8b98-a9b8ca30b163

Public Version Date

November 27, 2019

Public Version Number

3

DI Record Publish Date

September 15, 2018

Package DI Number

24026704580075

Quantity per Package

10

Contains DI Package

04026704580071

Package Discontinue Date

September 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Case