Catalog Number

-

Brand Name

Breath syst 22mm Heater Humidif.Si

Version/Model Number

6695165

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 10, 2019

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

-

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

CAI

Product Code Name

Circuit, Breathing (W Connector, Adaptor, Y Piece)

Public Device Record Key

e1fe6777-e119-4d6b-a6f3-6d337478fc26

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

November 04, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-