DG Health One Step Pregnancy Test

GUDID 00430000702077

FHC-102H Dollar General Preg One Step Cassette

DOLGENCORP, LLC

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Primary Device ID	00430000702077
NIH Device Record Key	f1234d07-e812-41f1-a6da-0aa568982c77
Commercial Distribution Status	In Commercial Distribution
Brand Name	DG Health One Step Pregnancy Test
Version Model Number	FHC-102H
Company DUNS	068331990
Company Name	DOLGENCORP, 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	false
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

Customer Support Contacts

Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx
Phone	888-309-9030
Email	xx@xx.xx

Operating and Storage Conditions

Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00430000702077 [Primary]
GS1	10430000702074 [Package] Package: Shipping Case [96 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K012215

FDA Product Code

LCX	Kit, Test, Pregnancy, Hcg, 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	2016-06-30

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