OneDraw A1C Test System

GUDID 00086303000046

The OneDraw™ A1C Test System is a single-use, sterile, capillary blood specimen collection, stabilization, and transportation system. The device incorporates lancets to make two small incisions in the skin and a vacuum to draw blood at the surface of the skin and through channels to deposit the blood onto collection and stabilization matrices. The collection kit is designed to facilitate in vitro laboratory testing of blood samples for clinical chemistry assays. OneDraw™ includes a collection device, transport sleeve, accessories, and instructions needed to collect, package, and mail the sample collection cartridge to the certified clinical laboratory for HbA1c testing.

DRAWBRIDGE HEALTH, INC.

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• Primary Device ID: 00086303000046
• NIH Device Record Key: 4eb0b4e4-8775-4906-8337-1b096daa0ee0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneDraw A1C Test System
• Version Model Number: FD001
• Company DUNS: 048087575
• Company Name: DRAWBRIDGE HEALTH, 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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: 843-494-5082
• Email: general@dbhealth.com
• Phone: 843-494-5082
• Email: general@dbhealth.com
• Phone: 843-494-5082
• Email: general@dbhealth.com
• Phone: 843-494-5082
• Email: general@dbhealth.com
• Phone: 843-494-5082
• Email: general@dbhealth.com
• Phone: 843-494-5082
• Email: general@dbhealth.com
• Phone: 843-494-5082
• Email: general@dbhealth.com
• Phone: 843-494-5082
• Email: general@dbhealth.com
• Phone: 843-494-5082
• Email: general@dbhealth.com
• Phone: 843-494-5082
• Email: general@dbhealth.com
• Phone: 843-494-5082
• Email: general@dbhealth.com
• Phone: 843-494-5082
• Email: general@dbhealth.com
• Phone: 843-494-5082
• Email: general@dbhealth.com
• Phone: 843-494-5082
• Email: general@dbhealth.com
• Phone: 843-494-5082
• Email: general@dbhealth.com
• Phone: 843-494-5082
• Email: general@dbhealth.com
• Phone: 843-494-5082
• Email: general@dbhealth.com
• Phone: 843-494-5082
• Email: general@dbhealth.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00086303000046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183230

FDA Product Code

• LCP: Assay, Glycosylated Hemoglobin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-23
• Device Publish Date: 2022-05-13