CUVETTES DC-80 Box 100 cuvettes - Plugs - Disposable cuvettes for use with the Oxicom 2100 - WATERS MEDICAL SYSTEMS, LLC

Duns Number:556957871

Device Description: Disposable cuvettes for use with the Oxicom 2100 and 3000 oximeter.

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More Product Details

Catalog Number

0010391.000

Brand Name

CUVETTES DC-80 Box 100 cuvettes - Plugs

Version/Model Number

DC-80 Cuvette Plugs

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

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

DQA

Product Code Name

Oximeter

Device Record Status

Public Device Record Key

68f54acc-2f91-4bdd-b043-c67705bae2a9

Public Version Date

March 21, 2019

Public Version Number

3

DI Record Publish Date

February 12, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WATERS MEDICAL SYSTEMS, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 53