GEM Premier 5000 PAK BG ISE GL COOX TBILI (600 TEST) - GEM 5000 BG ISE GL COOX TBILI 600 Test PAK 21 DAY - INSTRUMENTATION LABORATORY COMPANY

Duns Number:557223252

Device Description: GEM 5000 BG ISE GL COOX TBILI 600 Test PAK 21 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glu GEM 5000 BG ISE GL COOX TBILI 600 Test PAK 21 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glu, Lac, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, Tbili Cartridge)

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More Product Details

Catalog Number

00055360011XC

Brand Name

GEM Premier 5000 PAK BG ISE GL COOX TBILI (600 TEST)

Version/Model Number

00055360011XC

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

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

35c92dfc-2a66-4a1e-92b4-31f59561cf75

Public Version Date

July 14, 2021

Public Version Number

6

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