Catalog Number

1421047

Brand Name

RIP Thorax Processor - EmblaSleepmate

Version/Model Number

1421047

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 28, 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

K903300

Product Code

BZQ

Product Code Name

Monitor, breathing frequency

Public Device Record Key

277f9241-ba90-4f5f-8656-3aedb7af58d7

Public Version Date

December 31, 2018

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-