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

Kit, Test, Pregnancy, Hcg, Over The Counter (LCX) (3) Oximeter (DQA) (1) Pad, Heating, Powered (IRT) (1)

Premarket Exempt

No Yes

Clear

Good Sense - 00846036007695 Catalog Number :

Device Description : GoodSense Pulse Oximeter

Device Class : 2

Duns Number: 076059836

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

Good Sense - 00846036007701 Catalog Number :

Device Description : 12" x 24" Deluxe Moist/Dry Heating Pad

Device Class : 2

Duns Number: 076059836

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

Good Sense - 00846036009170 Catalog Number :

Device Description : Good Sense SPS +/- Blue Cap

Device Class : 2

Duns Number: 076059836

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

Good Sense - 00846036009187 Catalog Number :

Device Description : Good Sense DPS +/- Blue Cap

Device Class :

Duns Number: 076059836

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

GOODSENSE - 00846036009446 Catalog Number :

Device Description : One Step Pregnancy Test, 1 count

Device Class : 2

Duns Number: 076059836

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

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