KMART HOLDING CORPORATION

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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) Thermometer, Electronic, Clinical (FLL) (3) Tampon, Menstrual, Scented, Deodorized (HIL) (2) Tampon, Menstrual, Unscented (HEB) (2)

Premarket Exempt

Clear

Guaranteed Quality Products - 00072000758359 Catalog Number :

Device Description : A hand-held, battery-powered, electronic instrument designed for oral, under arm A hand-held, battery-powered, electronic instrument designed for oral, under arm or rectal use to measure a patient's body temperature. The device has a rigid tip and an LCD display. It is designed to take a temperature reading in approximately 10 seconds. This is a reusable device.

Device Class : 2

Duns Number: 131978533

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Guaranteed Quality Products - 00072000764978 Catalog Number :

Device Class :

Duns Number: 131978533

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Guaranteed Quality Products - 00072000783894 Catalog Number :

Device Description : A hand-held, battery-powered, electronic instrument designed for oral, under arm A hand-held, battery-powered, electronic instrument designed for oral, under arm or rectal use to measure a patient's body temperature. The device has a flexible tip and an LCD display. It is designed to take a temperature reading in approximately 10 seconds. This is a reusable device.

Device Class : 2

Duns Number: 131978533

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Smart Sense Early Result Pregnancy Test - 00072000793138 Catalog Number :

Device Description : PLPL Smart Sense DPS Early Kmart

Device Class :

Duns Number: 131978533

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

Image Essentials One Step Pregnancy Test - 00883967296910 Catalog Number :

Device Description : FPPL Kmart Image Essentials SPS +/-

Device Class :

Duns Number: 131978533

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

Image Essentials One Step Pregnancy Test - 00883967296927 Catalog Number :

Device Description : FPPL Kmart Image Essentials DPS +/-

Device Class :

Duns Number: 131978533

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

Smart Sense Tampons - 00883967382231 Catalog Number :

Device Class :

Duns Number: 131978533

Premarket Exempt : No

Product Code : HEB

Prescription Use : No

Device Count : 18

Smart Sense Tampons - 00883967382248 Catalog Number :

Device Class :

Duns Number: 131978533

Premarket Exempt : No

Product Code : HIL

Prescription Use : No

Device Count : 18

Smart Sense Tampons - 00883967382255 Catalog Number :

Device Class :

Duns Number: 131978533

Premarket Exempt : No

Product Code : HIL

Prescription Use : No

Device Count : 18

Smart Sense Tampons - 00883967382262 Catalog Number :

Device Class :

Duns Number: 131978533

Premarket Exempt : No

Product Code : HEB

Prescription Use : No

Device Count : 18

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