Primary Device ID | 00195226000641 |
NIH Device Record Key | 429af3fc-978c-4bf4-986d-cbe0e883f141 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 300 Tests) |
Version Model Number | 00077430010 |
Company DUNS | 557223252 |
Company Name | INSTRUMENTATION LABORATORY COMPANY |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
00195226000528 - ACL TOP 770 | 2024-05-23 ACL TOP 770 |
00195226000535 - ACL TOP 770 LAS | 2024-05-23 ACL TOP 770 LAS |
00195226000542 - ACL TOP 770s | 2024-05-23 ACL TOP 770s |
00195226000559 - ACL TOP 570 | 2024-05-23 ACL TOP 570 |
00195226000566 - ACL TOP 370 | 2024-05-23 ACL TOP 370 |
00195226000641 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 300 Tests) | 2023-10-11GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (300 Tests, 31 days) |
00195226000641 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 300 Tests) | 2023-10-11 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (300 T |
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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 |