Zacurate - Fingertip Pulse Oximeter - EINSTEIN ASSOCIATES LLC

Duns Number:080641505

Device Description: Fingertip Pulse Oximeter

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More Product Details

Catalog Number

M430N-DLBL-JPZA

Brand Name

Zacurate

Version/Model Number

500D Blue

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

OCH

Product Code Name

Oximeter, Infrared, Sporting, Aviation

Device Record Status

Public Device Record Key

d16a33a6-0f24-41f5-94ec-cd6d649d975a

Public Version Date

November 10, 2021

Public Version Number

3

DI Record Publish Date

October 30, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EINSTEIN ASSOCIATES LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 15