GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct 00044330008

GUDID 08426951070831

GEM Premier ChemSTAT PAK for Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct 300 test PAK

INSTRUMENTATION LABORATORY COMPANY

Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies

• Primary Device ID: 08426951070831
• NIH Device Record Key: 58d3e39e-849d-44ab-9fcc-43300216b165
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct
• Version Model Number: 00044330008
• Catalog Number: 00044330008
• 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: false
• 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

Customer Support Contacts

• Phone: +1 800-678-0710
• Email: techsupport@ilww.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
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• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
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Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426951070831 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183549

FDA Product Code

• JGS: Electrode, Ion Specific, Sodium

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-08
• Device Publish Date: 2019-06-28

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

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