ANGELINI PHARMA INC.

Address:9200 Corporate Blvd.,Rockville,MD,20850,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

Sterilant, Medical Devices (MED) (3) Dialyzer Reprocessing System (LIF) (2) Strip, Test, Reagent, Residuals For Dialysate, Disinfectant (MSY) (1)

Premarket Exempt

No Yes

Clear

Peracidin™ - 00898021000204 Catalog Number : 1632-55

Device Description : PAA Dialyzer Disinfectant.

Device Class : 2

Duns Number: 078843940

Premarket Exempt : No

Product Code : MED

Prescription Use : Yes

Device Count : 1

PeraSidual - 00898021000235 Catalog Number : 1702-01

Device Description : Reagent test strips used to measure the concentration of residual peroxide in ri Reagent test strips used to measure the concentration of residual peroxide in rinse water from dialyzers and dialysate lines disinfected with peroxide/peracetic acid.

Device Class : 2

Duns Number: 078843940

Premarket Exempt : No

Product Code : LIF

Prescription Use : No

Device Count : 1

PeraChek - 00898021000242 Catalog Number : 1701-01

Device Description : Reagent test strip for measuring the concentration of peracetic acid in dialyzer Reagent test strip for measuring the concentration of peracetic acid in dialyzer reprocessing.

Device Class : 2

Duns Number: 078843940

Premarket Exempt : No

Product Code : MSY, LIF

Prescription Use : No

Device Count : 1

Peracidin RO Disinfectant - 00898021000297 Catalog Number : 1633Q

Device Description : Peracidin® RO Disinfectant is intended for the disinfection of water purificatio Peracidin® RO Disinfectant is intended for the disinfection of water purification systems for hemodialysis.

Device Class : 2

Duns Number: 078843940

Premarket Exempt : Yes

Product Code : MED

Prescription Use : Yes

Device Count : 1

Peracidin RO Disinfectant - 00898021000303 Catalog Number : 1633G

Device Class : 2

Duns Number: 078843940

Premarket Exempt : Yes

Product Code : MED

Prescription Use : Yes

Device Count : 1

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