D-Care

GUDID 20370914001009

Glucose Monitoring Kit includes Glucose Meter, Test Strip, Lancing Device, Lancets and 7 Information Inserts.

HUDSON SCIENTIFIC, LLC

Home-use blood glucose spot-check analysis system Home-use blood glucose spot-check system Home-use blood glucose spot-check system Home-use blood glucose spot-check system Home-use blood glucose spot-check system Home-use blood glucose spot-check system Home-use blood glucose spot-check system Home-use blood glucose spot-check system Home-use blood glucose spot-check system Home-use blood glucose spot-check system Home-use blood glucose spot-check system Home-use blood glucose spot-check system Home-use blood glucose spot-check system Home-use blood glucose spot-check system

• Primary Device ID: 20370914001009
• NIH Device Record Key: 75b15c0f-4f54-42d8-b4af-e46e5e1024e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D-Care
• Version Model Number: 50001A
• Company DUNS: 080339637
• Company Name: HUDSON SCIENTIFIC, LLC
• 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: true
• 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: 5172124047
• Email: angela.powell@hudsci.com
• Phone: 5172124047
• Email: angela.powell@hudsci.com
• Phone: 5172124047
• Email: angela.powell@hudsci.com
• Phone: 5172124047
• Email: angela.powell@hudsci.com
• Phone: 5172124047
• Email: angela.powell@hudsci.com
• Phone: 5172124047
• Email: angela.powell@hudsci.com
• Phone: 5172124047
• Email: angela.powell@hudsci.com
• Phone: 5172124047
• Email: angela.powell@hudsci.com
• Phone: 5172124047
• Email: angela.powell@hudsci.com
• Phone: 5172124047
• Email: angela.powell@hudsci.com
• Phone: 5172124047
• Email: angela.powell@hudsci.com
• Phone: 5172124047
• Email: angela.powell@hudsci.com
• Phone: 5172124047
• Email: angela.powell@hudsci.com
• Phone: 5172124047
• Email: angela.powell@hudsci.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00370914001005 [Primary]
GS1	10370914001002 [Package]; Contains: 00370914001005; Package: Shipper [10 Units]; In Commercial Distribution
GS1	20370914001009 [Package]; Contains: 00370914001005; Package: Case [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132086

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-07-24

On-Brand Devices [D-Care]

• 00370914006017: DM2- kit contains one 60ct. bottle of Metformin 500mg and one 50ct. bottle Test Strips
• 00370914003054: Blood Glucose Test Strips (50 count)
• 20370914001009: Glucose Monitoring Kit includes Glucose Meter, Test Strip, Lancing Device, Lancets and 7 Informa