Catalog Number

69329

Brand Name

SleepmateThermocouple (Adult)

Version/Model Number

69329

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 02, 2020

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

K903300

Product Code

BZQ

Product Code Name

Monitor, breathing frequency

Public Device Record Key

7819c0b8-e730-486d-b1e8-cf3791d4f304

Public Version Date

November 03, 2020

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-