GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct 00044307508

GUDID 08426951070817

GEM Premier ChemSTAT PAK for Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct 75 test PAK

INSTRUMENTATION LABORATORY COMPANY

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Primary Device ID08426951070817
NIH Device Record Keyd821bb25-5d06-4714-a922-b8828bc6d970
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct
Version Model Number00044307508
Catalog Number00044307508
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

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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 at 15-25°C. DO NOT FREEZE. Do not unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
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 unpack the GEM Premier ChemSTAT PAK/cartridge from its protective wrapper until it is ready to be used.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108426951070817 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JGSElectrode, Ion Specific, Sodium

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-08
Device Publish Date2019-06-28

On-Brand Devices [GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct]

08426951070848GEM Premier ChemSTAT PAK for Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct 450 test PAK
08426951070831GEM Premier ChemSTAT PAK for Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct 300 test PAK
08426951070824GEM Premier ChemSTAT PAK for Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct 150 test PAK
08426951070817GEM Premier ChemSTAT PAK for Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct 75 test PAK

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