Santamedical - Santamedical Sports/Aviation Pulse Oximeter - GURIN PRODUCTS LLC

Duns Number:022069446

Device Description: Santamedical Sports/Aviation Pulse Oximeter

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More Product Details

Catalog Number

-

Brand Name

Santamedical

Version/Model Number

SM-110

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

b03c63c3-a800-4137-9cef-30aa6fe2c3c7

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

June 29, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GURIN PRODUCTS LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7