GEM 4000 PAK BG ISE GL COOX 450 TEST 30 DAY 00027445010

GUDID 08426950441304

GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 450 Test 30DAY

INSTRUMENTATION LABORATORY COMPANY

Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
Primary Device ID08426950441304
NIH Device Record Keya4b0386e-4173-4231-8119-30502eb86317
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEM 4000 PAK BG ISE GL COOX 450 TEST 30 DAY
Version Model Number00027445010
Catalog Number00027445010
Company DUNS557223252
Company NameINSTRUMENTATION LABORATORY COMPANY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-678-0710
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Phone1-800-678-0710
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Phone1-800-678-0710
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Phone1-800-678-0710
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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25°C. DO NOT FREEZE. Do not open cartridge bag until ready to use.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108426950441304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-07-09
Device Publish Date2016-09-23

Devices Manufactured by INSTRUMENTATION LABORATORY COMPANY

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00195226000627 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 600 Tests)2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (600 T
00195226000634 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 450 Tests)2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (450 T
00195226000658 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 150 Tests)2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (150 T
00195226000665 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 75 Tests)2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (75 Te
00195226000672 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 600 Tests)2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, tBili, O2Hb, COHb, HHb, MetHb, sO2
00195226000689 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 450 Tests)2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, tBili, O2Hb, COHb, HHb, MetHb, sO2
00195226000696 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 300 Tests)2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, tBili, O2Hb, COHb, HHb, MetHb, sO2

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