HEPRO.US 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

Syringe, Piston (FMF) (5) Polymer Patient Examination Glove (LZA) (2) Needle, Hypodermic, Single Lumen (FMI) (1) System, Test, Blood Glucose, Over The Counter (NBW) (1) Tubes, Vials, Systems, Serum Separators, Blood Collection (JKA) (1)

Premarket Exempt

Yes

Clear

Hepro.us - Disposable Syringe 3cc LL w/n 22G*1'' - 00850578007006 Catalog Number :

Device Description : Disposable Syringe 3cc LL w/n 22G*1''

Device Class : 2

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : FMF

Prescription Use : No

Device Count : 1

HEPRO.US - Disposable Syringe 3 ml/cc 23Gx1 1/2'' - 00850578007013 Catalog Number :

Device Description : Disposable Syringe 3 ml/cc with 23 G x 1 1/2'' needle

Device Class : 2

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : FMF

Prescription Use : No

Device Count : 1

HEPRO.US 5 ml/cc 23 G x 1 1/2" Single Syringe - 00850578007020 Catalog Number :

Device Description : HEPRO.US 5 ml/cc 23 G x 1 1/2" Single Syringe

Device Class : 2

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : FMF

Prescription Use : No

Device Count : 1

GLUCOSE TEST STRIP 50 CT. - 00850578007044 Catalog Number :

Device Description : HEPRO.US GLUCOSE TEST STRIPS 50units/BX for MM1000

Device Class :

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : NBW

Prescription Use : No

Device Count : 50

HEPRO.US Disposable Nitrile Gloves Class 450 Small - 00850578007174 Catalog Number :

Device Description : Hepro.us Disposable Nitrile Gloves Class 450Hepro.us Nitrile Disposable Gloves D Hepro.us Disposable Nitrile Gloves Class 450Hepro.us Nitrile Disposable Gloves Deluxe Class 450 Blue 9" Non Powdered Textured, Size Small 1 Box 100pcs

Device Class :

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : LZA

Prescription Use : No

Device Count : 100

HEPRO.US - Disposable Nitrile Gloves Class 400 Small - 00850578007181 Catalog Number :

Device Description : Hepro.us Nitrile Disposable Gloves Deluxe Class 400 Blue 9" Non Powdered Texture Hepro.us Nitrile Disposable Gloves Deluxe Class 400 Blue 9" Non Powdered Textured 1Case=10Boxes of 100pcs

Device Class :

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : LZA

Prescription Use : No

Device Count : 1000

HEPRO.US Blood Collection Vaccum Test Tube Gel Clot Activator - 00850578007211 Catalog Number :

Device Description : Blood Collection Vacuum Test Tube with Gel Blood Clot activator 5ml/100x100mmPET Blood Collection Vacuum Test Tube with Gel Blood Clot activator 5ml/100x100mmPET 100pcs/pk -1,000pcs/case

Device Class :

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : JKA

Prescription Use : No

Device Count : 1000

HEPRO.US - Blood Collection set with pre-attached holder 23Gx3/4"x12" Pack - 00850578007228 Catalog Number :

Device Description : Blood Collection SET with pre-attached holder 23G x 3/4" x 12" PE package 50pcs

Device Class :

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : FMI

Prescription Use : No

Device Count : 50

HEPRO.Us - Syringe 20ml/cc 18G x 1" 1 Box of 50pcs - 00850578007242 Catalog Number :

Device Description : Syringe with attached needle 20ml/cc 18G x 1" - 1 Box of 50pcs

Device Class :

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : FMF

Prescription Use : No

Device Count : 50

HEPRO.US Syringe with needle 5ml/cc 20G x1" - 00850578007266 Catalog Number :

Device Description : HEPRO.US - Syringe with attached needle 5ml/cc 20G x1" - 12 Boxes per Case

Device Class :

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : FMF

Prescription Use : No

Device Count : 1200

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