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.

Capillary blood collection system IVD
Primary Device ID00086303000046
NIH Device Record Key4eb0b4e4-8775-4906-8337-1b096daa0ee0
Commercial Distribution StatusIn Commercial Distribution
Brand NameOneDraw A1C Test System
Version Model NumberFD001
Company DUNS048087575
Company NameDRAWBRIDGE HEALTH, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone843-494-5082
Emailgeneral@dbhealth.com
Phone843-494-5082
Emailgeneral@dbhealth.com
Phone843-494-5082
Emailgeneral@dbhealth.com
Phone843-494-5082
Emailgeneral@dbhealth.com
Phone843-494-5082
Emailgeneral@dbhealth.com
Phone843-494-5082
Emailgeneral@dbhealth.com
Phone843-494-5082
Emailgeneral@dbhealth.com
Phone843-494-5082
Emailgeneral@dbhealth.com
Phone843-494-5082
Emailgeneral@dbhealth.com
Phone843-494-5082
Emailgeneral@dbhealth.com
Phone843-494-5082
Emailgeneral@dbhealth.com
Phone843-494-5082
Emailgeneral@dbhealth.com
Phone843-494-5082
Emailgeneral@dbhealth.com
Phone843-494-5082
Emailgeneral@dbhealth.com
Phone843-494-5082
Emailgeneral@dbhealth.com
Phone843-494-5082
Emailgeneral@dbhealth.com
Phone843-494-5082
Emailgeneral@dbhealth.com
Phone843-494-5082
Emailgeneral@dbhealth.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100086303000046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCPAssay, Glycosylated Hemoglobin

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-23
Device Publish Date2022-05-13

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