BRACCO DIAGNOSTICS 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

Insufflator, Automatic Carbon-Dioxide For Endoscope (FCX) (6) Catheter, Retention, Barium Enema With Bag (FGD) (1) Set, Administration, Intravascular (FPA) (1) System, X-Ray, Stationary (KPR) (1) Tray, Irrigation, Sterile (EYN) (1)

Premarket Exempt

No Yes

Clear

Fluid Administration Set - 10815112020016 Catalog Number : 000475

Device Description : Large Bore Tubing Administration Set

Device Class :

Duns Number: 849234661

Premarket Exempt : No

Product Code : EYN

Prescription Use : Yes

Device Count : 1

Solution Transfer Device - 10815112020115 Catalog Number : 005110

Device Description : US005110 I V Solution Transfer Kit

Device Class : 2

Duns Number: 849234661

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Protocol Colon Insufflator - 10815112020122 Catalog Number : 390301

Device Description : Protocol Colon Insufflator

Device Class : 2

Duns Number: 849234661

Premarket Exempt : No

Product Code : FCX

Prescription Use : Yes

Device Count : 1

Protocol Accessory Cart - 10815112020139 Catalog Number : 390305

Device Description : Protocol Acccessory Cart

Device Class : 2

Duns Number: 849234661

Premarket Exempt : No

Product Code : FCX

Prescription Use : Yes

Device Count : 1

Protocol Touch Colon Insufflator - 10815112020146 Catalog Number : 390308

Device Description : Protocol Touch Insufflator

Device Class : 2

Duns Number: 849234661

Premarket Exempt : No

Product Code : FCX

Prescription Use : Yes

Device Count : 1

Protocol Touch Administration Set with Small Catheter and Retention Cuff - 10815112020153 Catalog Number : 390309

Device Description : Protocol Touch Administration Set we/20fr. Tip

Device Class :

Duns Number: 849234661

Premarket Exempt : No

Product Code : FCX

Prescription Use : Yes

Device Count : 1

Protocol Administration Set With Flexi-Cuff Retention Tip - 10815112020160 Catalog Number : 390401

Device Description : Protocol Administration Set With Flexi-Cuff Retention Tip CO2 Delivery System fo Protocol Administration Set With Flexi-Cuff Retention Tip CO2 Delivery System for Colon Insufflation

Device Class :

Duns Number: 849234661

Premarket Exempt : No

Product Code : FCX

Prescription Use : Yes

Device Count : 1

Protocol Administration Set with Small Catheter and Retention Cuff - 10815112020177 Catalog Number : 390402

Device Description : Protocol Administration Set with Small Catheter and Retention Cuff CO2 Delivery Protocol Administration Set with Small Catheter and Retention Cuff CO2 Delivery System for Colon Insufflation

Device Class : 2

Duns Number: 849234661

Premarket Exempt : No

Product Code : FCX

Prescription Use : Yes

Device Count : 1

CT Enema Administration Kit: Enema Delivery System - 10815112020207 Catalog Number : 450002

Device Description : CT Enema Kit (Empty)

Device Class : 2

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : FGD

Prescription Use : Yes

Device Count : 1

Fast Find Grid: Disposable CT Biopsy Grid - 10815112020214 Catalog Number : 600001

Device Description : Fast Find Grid

Device Class :

Duns Number: 849234661

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 25

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