SIMPLE DIAGNOSTICS INC

Address:5208 Grand Ave,Maspeth,NY,11378,US

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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

Holding Chambers, Direct Patient Interface (NVP) (3) Nebulizer (Direct Patient Interface) (CAF) (2) Thermometer, Electronic, Clinical (FLL) (2) Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature (QRK) (1) Orthosis, Truncal/Orthosis, Limb (MRI) (1) Lancet, Blood (FMK) (1) Pump, Breast, Powered (HGX) (1)

Premarket Exempt

No Yes

Clear

Clever Choice - 00898302001388 Catalog Number :

Device Description : Anti-Static Holding Chamber for use with MDIs. Adult Sized Mask included.

Device Class :

Duns Number: 004135503

Premarket Exempt : No

Product Code : NVP

Prescription Use : Yes

Device Count : 1

Clever Choice - 00898302001395 Catalog Number :

Device Description : Anti-Static Holding Chamber for use with MDIs. Child Sized Mask included.

Device Class :

Duns Number: 004135503

Premarket Exempt : No

Product Code : NVP

Prescription Use : Yes

Device Count : 1

Clever Choice - 00898302001432 Catalog Number :

Device Description : Anti-Static Holding Chamber for use with MDIs. Infant Sized Mask included.

Device Class : 2

Duns Number: 004135503

Premarket Exempt : No

Product Code : NVP

Prescription Use : Yes

Device Count : 1

Clever Choice - 00898302001449 Catalog Number :

Device Description : Clever Choice Whisper Aire Nebulizer with mask and tubing

Device Class :

Duns Number: 004135503

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Clever Choice - 00898302001456 Catalog Number :

Device Description : Clever Choice Whisper Aire Pediatric Child Nebulizer with mask and tubing

Device Class : 2

Duns Number: 004135503

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Clever Choice - 00898302001463 Catalog Number : CLETEF-786

Device Description : Clever Choice Duo Ear & Forehead Thermometer - Infrared

Device Class :

Duns Number: 004135503

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Pharmacist Choice - 00898302001609 Catalog Number : 98302-0001-60

Device Description : Simple Diagnostics Lancets

Device Class : 2

Duns Number: 004135503

Premarket Exempt : No

Product Code : FMK, QRK

Prescription Use : No

Device Count : 1

Clever Choice - 00898302001869 Catalog Number : CLT-186

Device Description : Clever Choice Duo Ear & Forehead Thermometer - Infrared

Device Class : 2

Duns Number: 004135503

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Clever Choice - 00898302001876 Catalog Number :

Device Description : Dual Electric Breast Pump with dual phase design, individual control, and multi- Dual Electric Breast Pump with dual phase design, individual control, and multi-level suction control.

Device Class :

Duns Number: 004135503

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Clever Choice - 00898302001883 Catalog Number :

Device Description : Orthopedic Knee Brace

Device Class : 1

Duns Number: 004135503

Premarket Exempt : Yes

Product Code : MRI

Prescription Use : No

Device Count : 1

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