Catalog Number

0700-1004

Brand Name

PILLOW SENSOR,RESP,PHILIPS

Version/Model Number

Pillow Sensor, Respiration

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 03, 2022

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

-

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

b4486c04-0525-4efa-b02a-7027c0da7cf9

Public Version Date

June 13, 2022

Public Version Number

3

DI Record Publish Date

February 25, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-