KONQUEST - FINGERTIP PULSE OXIMENTER - KONQUEST GROUP INC

Duns Number:080939375

Device Description: FINGERTIP PULSE OXIMENTER

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More Product Details

Catalog Number

-

Brand Name

KONQUEST

Version/Model Number

KPO-1720

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

Yes

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 Details

Product Code

OCH

Product Code Name

Oximeter, Infrared, Sporting, Aviation

Device Record Status

Public Device Record Key

a29b4bff-6465-434c-b085-a447c1465324

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

September 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KONQUEST GROUP INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 9