Catalog Number

8014

Brand Name

HUDSON RCI

Version/Model Number

IPN045253

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

CBN

Product Code Name

APPARATUS, GAS-SCAVENGING

Public Device Record Key

59da0ca2-d2ee-482d-8fa6-6f79d825c759

Public Version Date

May 23, 2018

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

24026704582109

Quantity per Package

20

Contains DI Package

04026704582105

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case