CHAIN DRUG MARKETING ASSOCIATION, 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) (3) Needle, Hypodermic, Single Lumen (FMI) (2) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (2) First Aid Kit With Drug (LRR) (1) Kit, Test, Pregnancy, Hcg, Over The Counter (LCX) (1) Pad, Menstrual, Unscented (HHD) (1)

Premarket Exempt

No Yes

Clear

CDMA Quality Choice - Mini Pen Needles - 00635515959392 Catalog Number : AN 3590QC

Device Description : For use with injectors for the subcutaneous injection of approved drugs, including insulin

Device Class :

Duns Number: 011920774

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 100

Quality Choice - 00635515965010 Catalog Number :

Device Class : 2

Duns Number: 011920774

Premarket Exempt : Yes

Product Code : HHD

Prescription Use : No

Device Count : 40

Quality Choice - 00635515966130 Catalog Number : QC-96613

Device Description : Mini First Aid Kit

Device Class :

Duns Number: 011920774

Premarket Exempt : Yes

Product Code : LRR

Prescription Use : No

Device Count : 1

Quality Choice - 00635515966789 Catalog Number :

Device Class : 2

Duns Number: 011920774

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Quality Choice - 00635515966796 Catalog Number :

Device Class : 2

Duns Number: 011920774

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

CDMA Quality Choice - 4mm pen needles - 00635515969438 Catalog Number : AN 3540QC

Device Description : For use with injectors for the subcutaneous injection of approved drugs, including insulin

Device Class :

Duns Number: 011920774

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 100

Quality Choice Early Result Pregnancy Test - 00635515970717 Catalog Number :

Device Description : PLPL Quality Choice DPS Early

Device Class :

Duns Number: 011920774

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

QUALITY CHOICE - 00635515986701 Catalog Number : QC-98670

Device Description : Quality Choice 3-Pack Pedia Pets Thermometer Set

Device Class :

Duns Number: 011920774

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

QUALITY CHOICE - 00635515986787 Catalog Number : QC-98678

Device Description : Quality Choice Instant Ear Thermometer

Device Class :

Duns Number: 011920774

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

QUALITY CHOICE - 00635515986794 Catalog Number : QC-98679

Device Description : Quality ChoiceEconomy Pulse Oximeter

Device Class :

Duns Number: 011920774

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

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