Catalog Number

29-6030

Brand Name

Astrapulse Pulse Oximeter

Version/Model Number

Pediatric

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 2020

Issuing Agency

In HIBCC

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)

-

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

577be997-d0c8-4e27-9c48-309e6ac7d56b

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

September 02, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-