Catalog Number

1695

Brand Name

HUDSON RCI

Version/Model Number

IPN042730

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

K871157,K871157

Product Code

BZD

Product Code Name

VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Public Device Record Key

05661de3-bbad-4734-8ac4-4537c9629de9

Public Version Date

March 22, 2022

Public Version Number

6

DI Record Publish Date

September 16, 2016

Package DI Number

24026704595321

Quantity per Package

10

Contains DI Package

04026704595327

Package Discontinue Date

September 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Case