Assure® Platinum Blood Glucose Meter

GUDID 30015482501779

Assure Platinum Meter Institutional multi-pack (4 Assure Platinum meter kits PN 500001)

ARKRAY USA, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 30015482501779
• NIH Device Record Key: 55160898-02eb-46b7-81df-8cd9b475aa7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Assure® Platinum Blood Glucose Meter
• Version Model Number: 501177
• Company DUNS: 008171162
• Company Name: ARKRAY USA, 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: 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(800)818-8877
• Email: xxx@xxx.xxx
• Phone: +1(800)818-8877
• Email: xxx@xxx.xxx
• Phone: +1(800)818-8877
• Email: xxx@xxx.xxx
• Phone: +1(800)818-8877
• Email: xxx@xxx.xxx
• Phone: +1(800)818-8877
• Email: xxx@xxx.xxx
• Phone: +1(800)818-8877
• Email: xxx@xxx.xxx
• Phone: +1(800)818-8877
• Email: xxx@xxx.xxx
• Phone: +1(800)818-8877
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	30015482501779 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092104

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

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: 2022-06-27
• Device Publish Date: 2022-06-17

Devices Manufactured by ARKRAY USA, INC.

• 00015482183103 - SPOTCHEM™ EZ Analyzer: 2024-05-31 Dry Chemistry Analyzer IVD, semi-automated
• 00015482771010 - SPOTCHEM™ II Glucose: 2024-05-31 Strip description for the invitro quantitative determination of glucose in human plasma from whole blood samples
• 00015482771027 - SPOTCHEM™ II Uric Acid: 2024-05-31 Strip description for the invitro quantitative determination of uric acid concentration in human plasma from whole blood samples
• 00015482771034 - SPOTCHEM™ II Total Cholesterol: 2024-05-31 Strip description for the invitro quantitative determination of total cholesterol in human plasma from whole blood samples
• 00015482771041 - SPOTCHEM™ II Triglycerides: 2024-05-31 Strip is for invitro quantitative determination of triglycerides in human plasma from whole blood samples
• 00015482771058 - SPOTCHEM™ II BUN: 2024-05-31 Strip description for the invitro quantitative determination of blood urea nitrogen in human plasma from whole blood samples
• 00015482771065 - SPOTCHEM™ II Total Bilirubin: 2024-05-31 Strip description for the invitro quantitative determination of total bilirubin concentration in human plasma from whole blood s
• 00015482771072 - SPOTCHEM™ II Calcium: 2024-05-31 Strip description for the invitro quantitative determination of calcium concentration in human plasma from whole blood samples