Catalog Number

5-15110

Brand Name

HUDSON RCI

Version/Model Number

IPN048990

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

BSR

Product Code Name

STYLET, TRACHEAL TUBE

Public Device Record Key

23549c5f-fec7-497c-8b73-7536abfeac8b

Public Version Date

August 19, 2020

Public Version Number

2

DI Record Publish Date

September 20, 2018

Package DI Number

44026704617355

Quantity per Package

4

Contains DI Package

34026704617358

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case