Catalog Number

1638

Brand Name

HUDSON RCI

Version/Model Number

IPN042673

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

BYX

Product Code Name

TUBING, PRESSURE AND ACCESSORIES

Public Device Record Key

dceba315-6381-4286-942f-24cc33de3dea

Public Version Date

October 21, 2020

Public Version Number

4

DI Record Publish Date

September 15, 2018

Package DI Number

24026704594959

Quantity per Package

50

Contains DI Package

04026704594955

Package Discontinue Date

August 27, 2018

Package Status

Not in Commercial Distribution

Package Type

Case