AimStrip Tandem Glucose control solution

GUDID 00695684775124

blood glucose meter and test strip control solution-level 1,2,3

OSANG HEALTHCARE Co., Ltd.

Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control

• Primary Device ID: 00695684775124
• NIH Device Record Key: 9c738fe7-1a3c-4e85-be4d-4d2d4420ba98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AimStrip Tandem Glucose control solution
• 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: 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: 1-800-854-8446
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00695684775124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130295

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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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