Equate First Signal

GUDID 10681131175989

FHC-102H Walmart First Signal Preg Cassette

WAL-MART STORES, INC.

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

Primary Device ID	10681131175989
NIH Device Record Key	3ec5d14b-3bfd-4b00-9829-d0701627c30a
Commercial Distribution Status	In Commercial Distribution
Brand Name	Equate First Signal
Version Model Number	One Step Pregnancy Test
Company DUNS	051957769
Company Name	WAL-MART STORES, 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	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	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
Email	xx@xx.xx
Phone	1-888-287-1915
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
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681131175982 [Primary]
GS1	10681131175989 [Package] Contains: 00681131175982 Package: Shipping case [48 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	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2018-10-29
Device Publish Date	2018-09-28

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