MCKESSON 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) (5) Thermometer, Electronic, Clinical (FLL) (4) Pad, Heating, Powered (IRT) (1)

Premarket Exempt

No Yes

Clear

Sunmark Pregnancy Test Early Result - 00010939118448 Catalog Number :

Device Description : PLPL Sunmark DPS Early Result

Device Class :

Duns Number: 177667227

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

Sunmark Pregnancy Test One Step - 00010939162335 Catalog Number :

Device Description : FPPL Sunmark SPS +/-

Device Class :

Duns Number: 177667227

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

Sunmark Pregnancy Test One Step - 00010939163332 Catalog Number :

Device Description : FPPL Sunmark DPS +/-

Device Class :

Duns Number: 177667227

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

Sunmark - 00010939325440 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: 177667227

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Sunmark - 00010939343444 Catalog Number :

Device Class : 2

Duns Number: 177667227

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Sunmark - 00010939494443 Catalog Number : KD-2280.SMK

Device Description : A hand-held, battery-powered, electronic instrument designed to measure a patien A hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature from their temporal artery. The device has a flexible tip and an LCD display. It is designed to take a temperature reading in approximately 5 seconds. This is a reusable device.

Device Class : 2

Duns Number: 177667227

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

sunmark - 00010939938442 Catalog Number :

Device Class : 2

Duns Number: 177667227

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

Sunmark - 00010939953872 Catalog Number :

Device Description : Sunmark SPS +/- Blue Cap

Device Class : 2

Duns Number: 177667227

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

Sunmark - 00010939953889 Catalog Number :

Device Description : FPPL Sunmark DPS +/-

Device Class :

Duns Number: 177667227

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

Sunmark - 00038703000072 Catalog Number :

Device Description : 50 pack of probe covers. A device intended to be used as a physical barrier betw 50 pack of probe covers. A device intended to be used as a physical barrier between the patient and the probe of a thermometer to prevent cross-contamination between patients. This is a single-use device.

Device Class : 2

Duns Number: 177667227

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

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