Catalog Number

540212017

Brand Name

SPUR® II Infant Resuscitatorw/Expiratory Filter & Manometer

Version/Model Number

540212017

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

May 31, 2026

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

Yes

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

BTM

Product Code Name

Ventilator, emergency, manual (resuscitator)

Public Device Record Key

712d1f03-b766-4011-96a0-4e64e9f7af71

Public Version Date

June 01, 2021

Public Version Number

3

DI Record Publish Date

December 19, 2016

Package DI Number

05707480047758

Quantity per Package

12

Contains DI Package

05707480046317

Package Discontinue Date

May 31, 2021

Package Status

Not in Commercial Distribution

Package Type

-