GEM Premier 5000 PAK BG/ISE/COOX 300 TEST

Basic Information

• Brand Name: GEM Premier 5000 PAK BG/ISE/COOX 300 TEST
• Primary DI: 08426950807735
• Version / Model: 00055430008
• Catalog Number: 00055430008
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• Labeler DUNS: 557223252
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-24
• Public Version: 8
• Public Version Date: 2023-08-04
• Public Version Status: Update
• Public Device Record Key: 3cc036a9-592f-43b8-9e3e-4888ee3eeaec

Device Description

GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 300 Test 31 Days

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH	Clinical Chemistry	862.1120	2
GHS	Assay, Carboxyhemoglobin	Hematology	864.7425	2
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	862.1145	2
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	862.1665	2
GLY	Oximeter To Measure Hemoglobin	Hematology	864.7500	2
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	862.1600	2
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	862.1170	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52858	Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies	A collection of reagents and other associated materials intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample, using multiple technologies such as ion-selective electrode (ISE) and haemoximetry in a single analyser. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426950807735	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K160225	000
K160415	000
K173403	000
K203790	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.