AimStrip Tandem Lipid Profile and glucose measuring system

GUDID 00695684773014

Lipid and Glucose Measuring System

OSANG HEALTHCARE Co., Ltd.

Glucose/ketone/lipid profile IVD, kit, enzyme chemiluminescence

• Primary Device ID: 00695684773014
• NIH Device Record Key: 4efcb199-ffff-49f3-97c5-f29659b56c41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AimStrip Tandem Lipid Profile and glucose measuring system
• Version Model Number: ILM-0001A
• Company DUNS: 688195374
• Company Name: OSANG HEALTHCARE Co., Ltd.
• 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: false
• 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: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com
• Phone: 1-800-854-8446
• Email: sales@germainelabs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00695684773014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130295

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: 2020-03-23
• Device Publish Date: 2020-03-13

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