HEPRO.US INC.

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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) (8) Glucose Oxidase, Glucose (CGA) (1) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1) System, Test, Blood Glucose, Over The Counter (NBW) (1)

Premarket Exempt

Yes

Clear

HEPRO.US - Syringe with attached needle 5ml/cc 22G x1" - 00850578007273 Catalog Number :

Device Description : Hepro.us - Syringe with attached needle 5ml/cc 22G x1" - 100 pcs per box, 12 box Hepro.us - Syringe with attached needle 5ml/cc 22G x1" - 100 pcs per box, 12 box per carton

Device Class :

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : FMF

Prescription Use : No

Device Count : 1200

HEPRO.US Syringe with attached needle 5ml/cc 23G x 1 1/2" - 00850578007280 Catalog Number :

Device Description : Hepro.us - Syringe with attached needle 5ml/cc 23G x 1 1/2" - 100 pcs per box, 1 Hepro.us - Syringe with attached needle 5ml/cc 23G x 1 1/2" - 100 pcs per box, 12 box per carton

Device Class :

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : FMF

Prescription Use : No

Device Count : 1200

HEPRO.US - Syringe with needle 3ml/cc 22G x 3/4" - 12 Boxes per 1 Case - 00850578007297 Catalog Number :

Device Description : HEPRO.US - Syringe with attached needle 3ml/cc 22G x 3/4" - 100 pcs per Box, 12 HEPRO.US - Syringe with attached needle 3ml/cc 22G x 3/4" - 100 pcs per Box, 12 box per carton

Device Class :

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : FMF

Prescription Use : No

Device Count : 1200

HEPRO.US - Syringe with needle 1ml/cc 28G x1/2" - 00850578007327 Catalog Number :

Device Description : Hepro.us - Syringe with attached needle 1ml/cc 28G x1/2" - 100 pcs per box, 20 B Hepro.us - Syringe with attached needle 1ml/cc 28G x1/2" - 100 pcs per box, 20 Box per Carton

Device Class :

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : FMF

Prescription Use : No

Device Count : 2000

HEPRO.US 1ml/cc 31G x 5/16" Case - 00850578007334 Catalog Number :

Device Description : HEPRO.US 1ml/cc 31G x 5/16" Case

Device Class :

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : FMF

Prescription Use : No

Device Count : 2000

HEPRO.US - Tuberculin Syringe attached needle, 1ml/cc 25G x 5/8" - 00850578007365 Catalog Number :

Device Description : Tuberculin Syringe permanently attached needle, 1ml/cc 25G x 5/8", 10 pcs per Ba Tuberculin Syringe permanently attached needle, 1ml/cc 25G x 5/8", 10 pcs per Bag, 10 Bags per Box

Device Class :

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : FMF

Prescription Use : No

Device Count : 100

HEPRO.US - MM 1000 Test Strips Case - 00850578007389 Catalog Number :

Device Description : Case/Carton of 425 boxes of 50 TEST STRIPS HEPRO.US MM1000 - the FDA number is 3 Case/Carton of 425 boxes of 50 TEST STRIPS HEPRO.US MM1000 - the FDA number is 3012098689 - the operator number is 10049962

Device Class :

Duns Number: 080061451

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 21250

HEPRO.US MM1000 BRAND CT40 GLUCOSEMETER KIT - - 00850578007396 Catalog Number :

Device Description : Case/Carton of 40 boxes of ONE GLUCOSEMETER KIT HEPRO.US MM1000 Copy

Device Class :

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : NBW, JJX, CGA

Prescription Use : No

Device Count : 40

HEPRO.US - Tuberculin Syringes - 1ml/cc 25G x 5/8" - 00850578007426 Catalog Number :

Device Description : 30 Boxes per Case - 10 Bags of HEPRO.US - Tuberculin Syringe attached needle, 1 30 Boxes per Case - 10 Bags of HEPRO.US - Tuberculin Syringe attached needle, 1ml/cc 25G x 5/8"

Device Class :

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : FMF

Prescription Use : No

Device Count : 3000

HEPRO.US Insulin Syringes attached needle 0.3ml/cc 29G x 5/16" - 00850578007457 Catalog Number :

Device Description : Case of 20 boxes of Insulin Syringes attached needle 0.3ml/cc 29G x 5/16"

Device Class :

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : FMF

Prescription Use : No

Device Count : 2000

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