ContrIL Spectrum Control, Level 1 - ContrIL Spectrum Control, Level 1 - INSTRUMENTATION LABORATORY COMPANY

Duns Number:557223252

Device Description: ContrIL Spectrum Control, Level 1

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More Product Details

Catalog Number

00009833750

Brand Name

ContrIL Spectrum Control, Level 1

Version/Model Number

00009833750

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 09, 2018

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

JJS

Product Code Name

CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)

Device Record Status

Public Device Record Key

5d3728a2-4f59-432c-8c04-db5aad2ce85a

Public Version Date

July 13, 2021

Public Version Number

5

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INSTRUMENTATION LABORATORY COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 272