Catalog Number

-

Brand Name

Medisize®

Version/Model Number

356 001 010B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 12, 2020

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

BTT

Product Code Name

Humidifier, Respiratory Gas, (Direct Patient Interface)

Public Device Record Key

92dc062f-0875-4b4c-a0b2-f6b76959e2b1

Public Version Date

May 14, 2020

Public Version Number

3

DI Record Publish Date

October 07, 2016

Package DI Number

28717146000400

Quantity per Package

4

Contains DI Package

18717146000403

Package Discontinue Date

May 12, 2020

Package Status

Not in Commercial Distribution

Package Type

Case