GEM Premier 3000 iQM - BG HCT - 75 Tests 00024407584

GUDID 08426950088189

GEM Premier 3000 iQM 4WK - BG HCT - 75 Tests

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
Primary Device ID08426950088189
NIH Device Record Key4a13e3bf-6d52-41ed-a75e-c3e917cf4f5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEM Premier 3000 iQM - BG HCT - 75 Tests
Version Model Number00024407584
Catalog Number00024407584
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
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
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

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.

Device Identifiers

Device Issuing AgencyDevice ID
GS108426950088189 [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 Date2021-07-08
Device Publish Date2016-09-23

On-Brand Devices [GEM Premier 3000 iQM - BG HCT - 75 Tests]

08426950088189GEM Premier 3000 iQM 4WK - BG HCT - 75 Tests
08426950087960GEM Premier 3000 iQM 3WK - BG HCT - 75 Tests
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