Medichoice - Cable Extension/Adapter SpO2 3.0m Nellcor Oxi - OWENS & MINOR DISTRIBUTION, INC.

Duns Number:007941230

Device Description: Cable Extension/Adapter SpO2 3.0m Nellcor Oxi Compatible Reusable Not Made With Natural Ru Cable Extension/Adapter SpO2 3.0m Nellcor Oxi Compatible Reusable Not Made With Natural Rubber Latex MediChoice

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More Product Details

Catalog Number

-

Brand Name

Medichoice

Version/Model Number

CL4104

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"

Yes

For Single-Use

-

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 Details

Product Code

DQA

Product Code Name

Oximeter

Device Record Status

Public Device Record Key

a7f34106-559e-4280-8773-b46917930b8d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OWENS & MINOR DISTRIBUTION, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 428
2 A medical device with a moderate to high risk that requires special controls. 8754
U Unclassified 1