ChemSTAT System Evaluator 2 00044000102

GUDID 08426951293803

ChemSTAT System Evaluator 2, 10 ampoules x 1.8 mL

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
Primary Device ID08426951293803
NIH Device Record Keyca50a03a-1ab4-4272-a1a6-be043eeba1cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameChemSTAT System Evaluator 2
Version Model Number00044000102
Catalog Number00044000102
Company DUNS557223252
Company NameINSTRUMENTATION LABORATORY COMPANY
Device Count10
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Phone+1 800-678-0710
Emailtechsupport@ilww.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Unopened ampoules are stable when stored at 2-8°C until the expiration date shown on the label. DO NOT FREEZE.

Device Identifiers

Device Issuing AgencyDevice ID
GS108426951293803 [Primary]
GS118426951293800 [Unit of Use]

FDA Product Code

JJYMulti-Analyte Controls, All Kinds (Assayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-04
Device Publish Date2019-06-26

Devices Manufactured by INSTRUMENTATION LABORATORY COMPANY

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
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.