CVS Health At Home A1C Test Kit 3059

GUDID 00050428526859

Glycated haemoglobin (HbA1c) monitoring system IVD, home-use

Primary Device ID	00050428526859
NIH Device Record Key	e0eac44a-41cb-4b5e-be3d-1914a3631e5e
Commercial Distribution Status	In Commercial Distribution
Brand Name	CVS Health At Home A1C Test Kit
Version Model Number	3059
Catalog Number	3059
Company DUNS	062312574
Company Name	WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Device Count	2
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does n
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
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	false
OTC Over-The-Counter	true

Phone	1-800-746-7287
Email	xx@xx.xx

Storage Environment Temperature	Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Store out of direct sunlight.
Special Storage Condition, Specify	Between 0 and 0 *Do not use if dot is red or if the product is past the expiration date.
Special Storage Condition, Specify	Between 0 and 0 *Use indoors at room temperature.

Device Issuing Agency	Device ID
GS1	00050428526859 [Primary]
GS1	10050428526856 [Unit of Use]

LCP	Assay, Glycosylated Hemoglobin

Steralize Prior To Use	false
Device Is Sterile	false

00050428526859	The CVS Health At Home A1C Test Kit provides quantitative measurement of the percent of glycated
00050428350423	The CVS Health At Home A1C Test Kit provides quantitative measurement of the percent of glycated