Catalog Number

1418

Brand Name

HUDSON RCI

Version/Model Number

IPN042467

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

BZO

Product Code Name

SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)

Public Device Record Key

32d5edda-520f-4d62-9976-0af322f6efb4

Public Version Date

December 17, 2019

Public Version Number

2

DI Record Publish Date

September 15, 2018

Package DI Number

24026704594706

Quantity per Package

50

Contains DI Package

04026704594702

Package Discontinue Date

September 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Case