Catalog Number

5431

Brand Name

HUDSON RCI

Version/Model Number

IPN044960

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

BTC

Product Code Name

BAG, RESERVOIR

Public Device Record Key

ef85b422-4eca-4cd5-ab89-8e5afb159581

Public Version Date

December 11, 2019

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

24026704580372

Quantity per Package

20

Contains DI Package

04026704580378

Package Discontinue Date

September 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Case