Catalog Number

-

Brand Name

ReddyPort

Version/Model Number

RP-531-L1

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

K171827,K171827,K171827,K171827

Product Code

MNS

Product Code Name

Ventilator, Continuous, Non-Life-Supporting

Public Device Record Key

327384b2-aac6-4fb4-8ede-31d6b162e013

Public Version Date

November 05, 2020

Public Version Number

1

DI Record Publish Date

October 28, 2020

Package DI Number

10850001175002

Quantity per Package

10

Contains DI Package

00850001175005

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box