GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 1 GEN-CAL 1

GUDID 00851445007105

CALIBRATOR LEVEL 1 (CX 3)

GENCHEM INC

Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator

• Primary Device ID: 00851445007105
• NIH Device Record Key: a06aef32-2ccd-47eb-8310-d8c83d8f406f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 1
• Version Model Number: GEN-CAL 1
• Catalog Number: GEN-CAL 1
• Company DUNS: 193856866
• Company Name: GENCHEM INC
• 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: true
• Lot Batch: true
• Serial Number: false
• 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(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851445007105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090283

FDA Product Code

• JIX: CALIBRATOR, MULTI-ANALYTE MIXTURE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

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• 00851445007020 - GENCHEM™ Alkaline Phosphatase: 2018-07-06 ALP REAG. 1 (BULK)
• 00851445007037 - GENCHEM™ Alkaline Phosphatase: 2018-07-06 ALP REAG. 2 (BULK)
• 00851445007044 - GENCHEM™ Amylase Reagent: 2018-07-06 AMYLASE REAGENT
• 00851445007068 - GENCHEM™Electrode, Ion Specific, Urea Nitrogen (BUN) reagent: 2018-07-06 LX20 BUN
• 00851445007075 - GENCHEM™ Electrode, Ion Specific, Urea Nitrogen (BUN) reagent: 2018-07-06 BUN REAG. (CX3)
• 00851445007082 - GENCHEM™ UREA: 2018-07-06 BUN R1