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

Latex Patient Examination Glove (LYY) (5) Needle, Hypodermic, Single Lumen (FMI) (2) Surgeon'S Gloves (KGO) (2) Tubes, Vials, Systems, Serum Separators, Blood Collection (JKA) (1)

Premarket Exempt

Yes

Clear

HEPRO.US Blood Collection Sets with Pre-Attached Holder - 00850578007600 Catalog Number :

Device Description : Blood Collection Sets with Pre-Attached Holder Single 23G x 3/4 x 12"

Device Class : 2

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : FMI

Prescription Use : No

Device Count : 1

Hepro.us - Case of 10 Boxes of Blood collection sets with pre-attached hold - 00850578007617 Catalog Number :

Device Description : Case of 10 Boxes of Blood collection sets with pre-attached holder

Device Class :

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : FMI

Prescription Use : No

Device Count : 100

HEPRO.US - Gel & Clot Activator Tube - 00850578007631 Catalog Number :

Device Description : Gel & Clot Activator Tube, with serum for determinations in chemistry and serolo Gel & Clot Activator Tube, with serum for determinations in chemistry and serology. Pack of 100

Device Class :

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : JKA

Prescription Use : No

Device Count : 100

HEPRO.US Latex Examination Gloves Size Medium - 00850578007655 Catalog Number :

Device Description : Latex Examination Gloves 10 Boxes of 100 per Case total 1000 Size Medium

Device Class :

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : LYY

Prescription Use : No

Device Count : 1000

HEPRO.US Case of 10 boxes LARGE Latex Examination Gloves - 00850578007662 Catalog Number :

Device Description : Hepro.us - Case of 10 boxes of LARGE Latex Examination Gloves.

Device Class :

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : LYY

Prescription Use : No

Device Count : 1000

HEPRO.US - Latex Examination Gloves SMALL - 100 in one Box - 00850578007730 Catalog Number :

Device Description : Latex Examination Gloves, Ambidextrous, Non-Powder 9". Box of 100pcs. Size Small

Device Class :

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : LYY

Prescription Use : No

Device Count : 100

HEPRO.US – Latex Examination Gloves – 100 per Box - Size Medium - 00850578007754 Catalog Number :

Device Description : Latex Examination Gloves, Ambidextrous, Non-Powder 9” 100 pcs per Box Size Medium

Device Class :

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : LYY

Prescription Use : No

Device Count : 100

HEPRO.US Latex Examination Gloves Size Large - 00850578007761 Catalog Number :

Device Description : Latex Examination Gloves, Ambidextrous, Non-Powder 9” LargeHEPRO.US – Latex Exa Latex Examination Gloves, Ambidextrous, Non-Powder 9” LargeHEPRO.US – Latex Examination Gloves – Size Large 100 per Box

Device Class :

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : LYY

Prescription Use : No

Device Count : 100

HEPRO.US Sterile Latex Surgical Gloves 7" - 00850578007785 Catalog Number :

Device Description : Sterile Latex Surgical Gloves-Sterilized by Gamma Radiation- 50 Pairs per Box, S Sterile Latex Surgical Gloves-Sterilized by Gamma Radiation- 50 Pairs per Box, Size Small 7"

Device Class :

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : KGO

Prescription Use : No

Device Count : 50

HEPRO.US Sterile Latex Surgical Gloves 7.5" - 00850578007792 Catalog Number :

Device Description : Sterile Latex Surgical Gloves- Sterilized by Gamma Radiation- 50 Pairs per Box, Sterile Latex Surgical Gloves- Sterilized by Gamma Radiation- 50 Pairs per Box, Size Medium 7.5"

Device Class :

Duns Number: 080061451

Premarket Exempt : Yes

Product Code : KGO

Prescription Use : No

Device Count : 50

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