Catalog Number

817220-100

Brand Name

SleepmatePiezo Limb Sensor Kit (two limbs)

Version/Model Number

817220-100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

K935518,K935518

Product Code

BZQ

Product Code Name

Monitor, breathing frequency

Public Device Record Key

ebe77bf6-2f76-4dbe-bca1-d6f1a5169fa1

Public Version Date

October 29, 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

-