OneDraw A1C Test System

Basic Information

• Brand Name: OneDraw A1C Test System
• Primary DI: 00863030000408
• Version / Model: FD001
• Company Name: Drawbridge Health, Inc.
• Labeler DUNS: 048087575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-28
• Public Version: 1
• Public Version Date: 2023-01-05
• Public Version Status: New
• Public Device Record Key: 9b32db80-4477-47f6-9789-e1e42ec5dfcf

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LCP	Assay, Glycosylated Hemoglobin	Hematology	864.7470	2
PRJ	Capillary Blood Collection Device For Alternative Site Collection	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63061	Capillary blood collection system IVD	An assembly of devices intended to be used for the collection, preservation, and/or transportation of capillary blood for subsequent analysis and/or other investigation. It is a self-contained unit consisting of micro-needles and a container with a pre-measured amount of vacuum. The device is intended to be placed against the skin where the needles make shallow perforations, from which blood is drawn from the capillaries into the container via the vacuum. It may or may not contain a preservative or anticoagulant (e.g., lithium heparin). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00863030000408	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius