Catalog Number

819100-108

Brand Name

SleepmateRIPmate Kit - Integrated RIP Keyhole

Version/Model Number

819100-108

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

K903300,K903300

Product Code

BZQ

Product Code Name

Monitor, breathing frequency

Public Device Record Key

c87ff7d5-9d97-4a5b-ac64-bb9ef36f0a79

Public Version Date

October 29, 2018

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

-