Catalog Number

20201

Brand Name

MACS

Version/Model Number

MACS CPAP System

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K080692

Product Code

BTL

Product Code Name

Ventilator, Emergency, Powered (Resuscitator)

Public Device Record Key

007479be-0113-4f8d-bc61-221d9f300211

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 23, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-