Amerisourcebergen Drug 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

Thermometer, Electronic, Clinical (FLL) (2) Kit, Test, Pregnancy, Hcg, Over The Counter (LCX) (1) Needle, Hypodermic, Single Lumen (FMI) (1) Radioimmunoassay, Luteinizing Hormone (CEP) (1) Strip, Temperature, Forehead, Liquid Crystal (KPD) (1)

Premarket Exempt

No Yes

Clear

Good Neighbor Pharmacy - 00087701565809 Catalog Number :

Device Description : 25 pack of probe covers. A device intended to be used as a physical barrier betw 25 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: 007914906

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Good Neighbor Pharmacy - 00087701565847 Catalog Number :

Device Description : A hand-held, battery-powered, electronic instrument designed for oral, vaginal o A hand-held, battery-powered, electronic instrument designed for oral, vaginal or rectal use to measure a patient's basal body temperature for conception. The device has a rigid tip and an LCD display. It is designed to take a temperature reading in approximately 40 seconds. This is a reusable device.

Device Class : 2

Duns Number: 007914906

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Good Neighbor Pharmacy - 00087701565861 Catalog Number :

Device Description : A device designed to measure skin temperature at several different points using A device designed to measure skin temperature at several different points using liquid-crystal sensors that are sealed in a plastic band applied to the forehead. The device may be used in the home. This is a reusable device.

Device Class : 2

Duns Number: 007914906

Premarket Exempt : Yes

Product Code : KPD

Prescription Use : No

Device Count : 1

Good Neighbor Pharmacy - 00087701738319 Catalog Number :

Device Description : Good Neighbor Pharmacy One Step Ovulation Predictor 7ct

Device Class :

Duns Number: 007914906

Premarket Exempt : Yes

Product Code : CEP

Prescription Use : No

Device Count : 7

Good Neighbor Pharmacy One Step Pregnancy Test - 00087701894800 Catalog Number :

Device Description : FPPL Good Neighbor DPS +/-

Device Class :

Duns Number: 007914906

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

GNP - 00087710434349 Catalog Number :

Device Description : 8mm pen needle UltiGuard

Device Class :

Duns Number: 007914906

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

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