Catalog Number

IPR-250

Brand Name

WalkMed®

Version/Model Number

204822

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

5c0fb2cd-8157-4f4a-974a-22f2c9ddaa97

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

10859695006067

Quantity per Package

10

Contains DI Package

00859695006060

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Package of 10