GENCHEM™Electrode, Ion Specific, Urea Nitrogen (BUN) reagent GEN-BUN LX

GUDID 00851445007068

LX20 BUN

GENCHEM INC

Urea IVD, reagent

• Primary Device ID: 00851445007068
• NIH Device Record Key: cd918fab-9ddc-407c-ac90-6392003e912e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GENCHEM™Electrode, Ion Specific, Urea Nitrogen (BUN) reagent
• Version Model Number: GEN-BUN LX
• Catalog Number: GEN-BUN LX
• 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	00851445007068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040973

FDA Product Code

• CDS: ELECTRODE, ION SPECIFIC, UREA NITROGEN

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

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• 00851445007013 - GENCHEM™ Albumin Reagent: 2018-07-06 ALBUMIN BCG
• 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: 2018-07-06LX20 BUN
• 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