Catalog Number

207000

Brand Name

Breas iSleep 20i system

Version/Model Number

US

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 15, 2018

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

K063476,K063476

Product Code

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Public Device Record Key

6adde063-2d34-4293-a816-f5259869e7d8

Public Version Date

February 11, 2021

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

07321822070167

Quantity per Package

1

Contains DI Package

07321822070006

Package Discontinue Date

January 15, 2018

Package Status

Not in Commercial Distribution

Package Type

Box