Na/K/Cl/Li Solution Pack - Na/K/Cl/Li Solution Pack for use with EasyLyte - MEDICA CORPORATION

Duns Number:112942404

Device Description: Na/K/Cl/Li Solution Pack for use with EasyLyte Analyzers

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More Product Details

Catalog Number

2026

Brand Name

Na/K/Cl/Li Solution Pack

Version/Model Number

2026

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K963763

Product Code Details

Product Code

CEM

Product Code Name

Electrode, Ion Specific, Potassium

Device Record Status

Public Device Record Key

a26df5f8-eb11-4021-a2e0-63d6e1f1177e

Public Version Date

January 04, 2019

Public Version Number

1

DI Record Publish Date

December 04, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDICA CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 19
2 A medical device with a moderate to high risk that requires special controls. 82