On Call Express Blood Glucose Test Strips

GUDID 20024291121842

Blood Glucose Test Strips, box of 50 strips

NAVAJO MANUFACTURING COMPANY

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• Primary Device ID: 20024291121842
• NIH Device Record Key: 4e98178e-ac52-4082-a520-90b7856fd39d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: On Call Express Blood Glucose Test Strips
• Version Model Number: G-135-10D
• Company DUNS: 136941411
• Company Name: NAVAJO MANUFACTURING COMPANY
• Device Count: 50
• DM Exempt: true
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(303)292-3090
• Email: fmorales@navajoinc.com
• Phone: +1(303)292-3090
• Email: fmorales@navajoinc.com
• Phone: +1(303)292-3090
• Email: fmorales@navajoinc.com
• Phone: +1(303)292-3090
• Email: fmorales@navajoinc.com
• Phone: +1(303)292-3090
• Email: fmorales@navajoinc.com
• Phone: +1(303)292-3090
• Email: fmorales@navajoinc.com
• Phone: +1(303)292-3090
• Email: fmorales@navajoinc.com
• Phone: +1(303)292-3090
• Email: fmorales@navajoinc.com
• Phone: +1(303)292-3090
• Email: fmorales@navajoinc.com
• Phone: +1(303)292-3090
• Email: fmorales@navajoinc.com
• Phone: +1(303)292-3090
• Email: fmorales@navajoinc.com
• Phone: +1(303)292-3090
• Email: fmorales@navajoinc.com
• Phone: +1(303)292-3090
• Email: fmorales@navajoinc.com
• Phone: +1(303)292-3090
• Email: fmorales@navajoinc.com
• Phone: +1(303)292-3090
• Email: fmorales@navajoinc.com
• Phone: +1(303)292-3090
• Email: fmorales@navajoinc.com
• Phone: +1(303)292-3090
• Email: fmorales@navajoinc.com
• Phone: +1(303)292-3090
• Email: fmorales@navajoinc.com
• Phone: +1(303)292-3090
• Email: fmorales@navajoinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00024291121848 [Primary]
GS1	00024291122845 [Unit of Use]
GS1	10024291121845 [Package]; Contains: 00024291121848; Package: CARTON [3 Units]; In Commercial Distribution
GS1	20024291121842 [Package]; Contains: 10024291121845; Package: CASE [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132086

FDA Product Code

• CGA: GLUCOSE OXIDASE, GLUCOSE

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: 2020-04-07
• Device Publish Date: 2020-03-30

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