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

Lavage, Jet (FQH) (4) Set, Administration, For Peritoneal Dialysis, Disposable (KDJ) (2) Sterilant, Medical Devices (MED) (2) Catheter, Peritoneal Dialysis, Single Use (FKO) (1) Dialyzer Reprocessing System (LIF) (1)

Premarket Exempt

No Yes

Clear

Maky 21.1 - 00898021000037 Catalog Number : MAKY21.1

Device Description : Dialyzer reprocessing machine.

Device Class : 2

Duns Number: 078843940

Premarket Exempt : No

Product Code : LIF

Prescription Use : No

Device Count : 1

Alcavis 50 - 00898021000044 Catalog Number : 15508

Device Description : Electrolytic Chloroxidizer High Level Disinfectant.

Device Class :

Duns Number: 078843940

Premarket Exempt : No

Product Code : KDJ

Prescription Use : Yes

Device Count : 1

Alcavis 50 - 00898021000051 Catalog Number : 15501

Device Description : Electrolytic Chloroxidizer High Level Disinfectant.

Device Class : 2

Duns Number: 078843940

Premarket Exempt : No

Product Code : KDJ

Prescription Use : Yes

Device Count : 1

Alcavis 50 - 00898021000068 Catalog Number : 15502

Device Description : Electrolytic chloroxidizer high level disinfectant.

Device Class : 2

Duns Number: 078843940

Premarket Exempt : No

Product Code : FKO

Prescription Use : Yes

Device Count : 1

ExSept Plus - 00898021000075 Catalog Number : 15117

Device Description : Skin and wound cleanser.

Device Class : 2

Duns Number: 078843940

Premarket Exempt : No

Product Code : FQH

Prescription Use : Yes

Device Count : 1

ExSept Plus - 00898021000082 Catalog Number : 15108

Device Description : Skin and wound cleanser.

Device Class :

Duns Number: 078843940

Premarket Exempt : No

Product Code : FQH

Prescription Use : Yes

Device Count : 1

ExSept Plus - 00898021000099 Catalog Number : 15107

Device Description : Skin and wound cleanser.

Device Class :

Duns Number: 078843940

Premarket Exempt : No

Product Code : FQH

Prescription Use : Yes

Device Count : 1

ExSept Plus - 00898021000105 Catalog Number : 15104

Device Description : Skin and would cleanser.

Device Class : 2

Duns Number: 078843940

Premarket Exempt : No

Product Code : FQH

Prescription Use : Yes

Device Count : 1

Peracidin™ - 00898021000181 Catalog Number : 1632-12

Device Description : PAA Dialyzer Disinfectant.

Device Class :

Duns Number: 078843940

Premarket Exempt : No

Product Code : MED

Prescription Use : Yes

Device Count : 1

Peracidin™ - 00898021000198 Catalog Number : 1632-04

Device Description : PAA Dialyzer Disinfectant.

Device Class : 2

Duns Number: 078843940

Premarket Exempt : No

Product Code : MED

Prescription Use : Yes

Device Count : 1

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