GEISS, DESTIN & DUNN, INC

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Thermometer, Electronic, Clinical (FLL) (4) Kit, Test, Pregnancy, Hcg, Over The Counter (LCX) (3) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (2) Accessories, Soft Lens Products (LPN) (1)

Premarket Exempt

No Yes

Clear

Good Sense Early Result Pregnancy Test - 00846036006186 Catalog Number :

Device Description : Good Sense DPS Early

Device Class :

Duns Number: 076059836

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

Good Sense One Step Pregnancy Test - 00846036006391 Catalog Number :

Device Description : FPPL Good Sense SPS +/-

Device Class : 2

Duns Number: 076059836

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

Good Sense One Step Pregnancy Test - 00846036006407 Catalog Number :

Device Description : FPPL Good Sense DPS +/-

Device Class :

Duns Number: 076059836

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

Good Sense - 00846036006438 Catalog Number :

Device Description : 60 Second Rigid Digital Thermometer

Device Class : 2

Duns Number: 076059836

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Good Sense - 00846036006742 Catalog Number :

Device Class : 2

Duns Number: 076059836

Premarket Exempt : No

Product Code : LPN

Prescription Use : No

Device Count : 1

Good Sense - 00846036007343 Catalog Number : 69-330

Device Description : Good SenseTemple Touch Mini Thermometer

Device Class : 2

Duns Number: 076059836

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Good Sense - 00846036007350 Catalog Number :

Device Description : Good Sense Automatic Wrist Digital BP Unit

Device Class : 2

Duns Number: 076059836

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Good Sense - 00846036007367 Catalog Number :

Device Description : Good Sense Automatic Arm Digital BP Unit

Device Class : 2

Duns Number: 076059836

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Good Sense - 00846036007671 Catalog Number :

Device Description : 30 Second Rigid Tip Digital Thermometer

Device Class : 2

Duns Number: 076059836

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Good Sense - 00846036007688 Catalog Number :

Device Description : GoodSense 10 Second Flexible Tip Digital Thermometer

Device Class : 2

Duns Number: 076059836

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

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