Good Sense One Step Pregnancy Test

GUDID 00846036006407

FPPL Good Sense DPS +/-

GEISS, DESTIN & DUNN, INC

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Primary Device ID00846036006407
NIH Device Record Keyf3bd94e4-5dc0-424c-9957-c2c6bca629ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameGood Sense One Step Pregnancy Test
Version Model NumberFPPL
Company DUNS076059836
Company NameGEISS, DESTIN & DUNN, INC
Device Count2
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 Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx
Phone866-696-0957
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100633472000133 [Unit of Use]
GS100846036006407 [Primary]
GS110846036006404 [Package]
Package: Shipping Case [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCXKit, Test, Pregnancy, Hcg, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-30

On-Brand Devices [Good Sense One Step Pregnancy Test]

00846036006407FPPL Good Sense DPS +/-
10846036006398FPPL Good Sense SPS +/-

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