Catalog Number

1127364

Brand Name

RUSleeping RTS

Version/Model Number

RUSLEEPING RTS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 31, 9999

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K022294

Product Code

MNR

Product Code Name

VENTILATORY EFFORT RECORDER

Public Device Record Key

08a57005-4697-4a68-8052-e1b0f0de14c4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-