HR PHARMACEUTICALS INC.

HR PHARMACEUTICALS INC.

Address:3630 Concord Rd,York,PA,17402,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

APPLIANCE, COLOSTOMY, DISPOSABLE (EZS) (7) BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE (FAQ) (2) COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER (KNX) (1)

Premarket Exempt

No Yes

Clear

Vitus - 00850025153003 Catalog Number : 6050B

Device Description : Vitus Skin Prep Wipe

Device Class :

Duns Number: 828918164

Premarket Exempt : Yes

Product Code : EZS

Prescription Use : No

Device Count : 1

Vitus - 00850025153010 Catalog Number : 7050R

Device Description : Vitus Adhesive Remover Wipe

Device Class : 1

Duns Number: 828918164

Premarket Exempt : Yes

Product Code : EZS

Prescription Use : No

Device Count : 1

Vitus - 00850025153027 Catalog Number : 520

Device Description : Vitus 2" Seal Thin

Device Class : 1

Duns Number: 828918164

Premarket Exempt : Yes

Product Code : EZS

Prescription Use : No

Device Count : 1

Vitus - 00850025153034 Catalog Number : 521

Device Description : Vitus 2" Seal Standard

Device Class : 1

Duns Number: 828918164

Premarket Exempt : Yes

Product Code : EZS

Prescription Use : No

Device Count : 1

Vitus - 00850025153041 Catalog Number : 522

Device Description : Vitus 4" Seal

Device Class :

Duns Number: 828918164

Premarket Exempt : Yes

Product Code : EZS

Prescription Use : No

Device Count : 1

Vitus - 00850025153096 Catalog Number : 500

Device Description : Vitus 2oz Paste

Device Class :

Duns Number: 828918164

Premarket Exempt : Yes

Product Code : EZS

Prescription Use : No

Device Count : 1

Vitus - 00850025153102 Catalog Number : 501

Device Description : Vitus 2oz Paste No Sting

Device Class :

Duns Number: 828918164

Premarket Exempt : Yes

Product Code : EZS

Prescription Use : No

Device Count : 1

TruCath - 00850025153119 Catalog Number : HRLB500

Device Description : TruCath Premium Leg Bag 500mL

Device Class : 1

Duns Number: 828918164

Premarket Exempt : Yes

Product Code : FAQ

Prescription Use : Yes

Device Count : 1

TruCath - 00850025153126 Catalog Number : HRLB1000

Device Description : TruCath Premium Leg Bag 1000mL

Device Class : 1

Duns Number: 828918164

Premarket Exempt : Yes

Product Code : FAQ

Prescription Use : Yes

Device Count : 1

TruCath - 00850025153133 Catalog Number : HRNB2000

Device Description : TruCath Night Drainage Bag 2000mL

Device Class : 2

Duns Number: 828918164

Premarket Exempt : Yes

Product Code : KNX

Prescription Use : Yes

Device Count : 1

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