Catalog Number

780-13

Brand Name

HUDSON RCI

Version/Model Number

IPN045196

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"

-

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

BZO

Product Code Name

SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)

Public Device Record Key

4d7af5c5-596c-4734-a3cd-17404944eb9e

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

September 15, 2018

Package DI Number

24026704398403

Quantity per Package

20

Contains DI Package

04026704398409

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case