Catalog Number

380315

Brand Name

HUDSON RCI

Version/Model Number

IPN044265

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

CAI

Product Code Name

Circuit, breathing (w connector, adaptor, y piece)

Public Device Record Key

a3e629ba-032a-4ef5-bac4-229fb144179c

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

September 15, 2018

Package DI Number

24026704580952

Quantity per Package

20

Contains DI Package

04026704580958

Package Discontinue Date

September 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Case