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

Catheter, Retention Type (EZK) (1) Catheter, Retention, Barium Enema With Bag (FGD) (1) Insufflator, Automatic Carbon-Dioxide For Endoscope (FCX) (1)

Premarket Exempt

No Yes

Clear

High Pressure DISS Hose For CO2 - 30815112020805 Catalog Number : 710604

Device Description : High Pressure DISS Hose

Device Class : 2

Duns Number: 849234661

Premarket Exempt : No

Product Code : FCX

Prescription Use : Yes

Device Count : 1

Tubing Clamp: Fits Standard 5/16' Tubing - 30815112020843 Catalog Number : 900401

Device Description : Tubing Clamp (Green)

Device Class :

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : FGD

Prescription Use : No

Device Count : 50

Enteroclysis Catheter 13Fx155cm - 30815112021093 Catalog Number : 901501

Device Description : Enteroclysis Cath 13F w/Ball

Device Class : 2

Duns Number: 849234661

Premarket Exempt : No

Product Code : EZK

Prescription Use : Yes

Device Count : 1

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