Wand, Bar Code - Wand, Bar Code (GEM 5000) - INSTRUMENTATION LABORATORY COMPANY

Duns Number:557223252

Device Description: Wand, Bar Code (GEM 5000)

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More Product Details

Catalog Number

00024015859

Brand Name

Wand, Bar Code

Version/Model Number

00024015859

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

K160412,K203790

Product Code Details

Product Code

CHL

Product Code Name

ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Device Record Status

Public Device Record Key

c9d075d9-b43a-4633-add7-7574bacd8a80

Public Version Date

September 30, 2021

Public Version Number

7

DI Record Publish Date

March 29, 2017

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