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

Syringe, Piston (FMF) (7) Garment, Protective, For Incontinence (EYQ) (1) Needle, Hypodermic, Single Lumen (FMI) (1) System, Test, Blood Glucose, Over The Counter (NBW) (1)

Premarket Exempt

No Yes

Clear

Clever Choice Comfort EZ - 00898302139319 Catalog Number : 98302-0139-31

Device Description : Insulin Syringe 30G .3cc 5/16"

Device Class :

Duns Number: 004135503

Premarket Exempt : No

Product Code : FMF

Prescription Use : No

Device Count : 100

Clever Choice Comfort EZ - 00898302139326 Catalog Number : 98302-0139-32

Device Description : Insulin Syringe 30G .5cc 5/16"

Device Class :

Duns Number: 004135503

Premarket Exempt : No

Product Code : FMF

Prescription Use : No

Device Count : 100

Clever Choice Comfort EZ - 00898302139333 Catalog Number : 98302-0139-33

Device Description : Insulin Syringe 30G 1cc 5/16"

Device Class :

Duns Number: 004135503

Premarket Exempt : No

Product Code : FMF

Prescription Use : No

Device Count : 100

Clever Choice Comfort EZ - 00898302139371 Catalog Number : 98302-0139-37

Device Description : Insulin Syringe 29G .5cc 1/2"

Device Class :

Duns Number: 004135503

Premarket Exempt : No

Product Code : FMF

Prescription Use : No

Device Count : 100

Clever Choice Comfort EZ - 00898302139395 Catalog Number : 98302-0139-39

Device Description : Insulin Syringe 28G .5cc 1/2"

Device Class :

Duns Number: 004135503

Premarket Exempt : No

Product Code : FMF

Prescription Use : No

Device Count : 100

Clever Choice Comfort EZ - 00898302139401 Catalog Number : 98302-0139-40

Device Description : Insulin Syringe 28G 1cc 1/2"

Device Class :

Duns Number: 004135503

Premarket Exempt : No

Product Code : FMF

Prescription Use : No

Device Count : 100

Clever Choice - 00898302139425 Catalog Number : 98302-1391-42

Device Description : Non-Retail Blood Glucose Test Strips for Clever Choice HD and Voice HD Blood Glu Non-Retail Blood Glucose Test Strips for Clever Choice HD and Voice HD Blood Glucose Meters.

Device Class :

Duns Number: 004135503

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 50

Clever Choice Comfort EZ - 00898302139449 Catalog Number : 98302-0139-38

Device Description : Insulin Syringe 29G 1cc 1/2". Bag of 10 Syringes.

Device Class :

Duns Number: 004135503

Premarket Exempt : No

Product Code : FMF

Prescription Use : No

Device Count : 10

Clever Choice Comfort EZ - 00898302140001 Catalog Number : 98302-0002-00

Device Description : Insulin Pen Needle 1/4 inch length and 31 gauge

Device Class :

Duns Number: 004135503

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

Clever Choice - 00898302140070 Catalog Number : 98302-0140-07

Device Description : Clever Choice Comfort Protect Adult Diapers - large

Device Class :

Duns Number: 004135503

Premarket Exempt : Yes

Product Code : EYQ

Prescription Use : No

Device Count : 10

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