ContrIL 7 Multipak 00024001380

GUDID 08426950061687

ContrIL 7 Multipak

INSTRUMENTATION LABORATORY COMPANY

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Primary Device ID08426950061687
NIH Device Record Key0a337240-89d3-483a-82fc-47a9b1f87cb8
Commercial Distribution StatusIn Commercial Distribution
Brand NameContrIL 7 Multipak
Version Model Number00024001380
Catalog Number00024001380
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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

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Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.

Device Identifiers

Device Issuing AgencyDevice ID
GS108426950061687 [Primary]

FDA Product Code

JJYMulti-analyte controls, all kinds (assayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-07-09
Device Publish Date2016-09-23

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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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