Primary Device ID | 08426951293865 |
NIH Device Record Key | 57e08ca9-d88f-4e67-aaa1-7c3ccfb81bcd |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GEM Premier ChemSTAT |
Version Model Number | 00044000000 |
Catalog Number | 00044000000 |
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 | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08426951293865 [Primary] |
CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-07-17 |
Device Publish Date | 2019-06-28 |
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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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GEM PREMIER CHEMSTAT 86815492 not registered Live/Pending |
Instrumentation Laboratory Company 2015-11-10 |