Catalog Number

531616000

Brand Name

SPUR® II Pediatric Resuscitator

Version/Model Number

531616000

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

2646c5ce-0c96-493d-b82a-13da1e717ad6

Public Version Date

June 01, 2021

Public Version Number

2

DI Record Publish Date

June 24, 2020

Package DI Number

05707480145324

Quantity per Package

6

Contains DI Package

05707480145317

Package Discontinue Date

May 31, 2021

Package Status

Not in Commercial Distribution

Package Type

-