Catalog Number

RL24-03IIY

Brand Name

NA

Version/Model Number

RL24-03IIY

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 29, 2021

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

K912415

Product Code

BZQ

Product Code Name

Monitor, breathing frequency

Public Device Record Key

e23c91b5-8743-4e2e-ab10-aefd223f999d

Public Version Date

June 01, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-