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, Barium Enema With Bag (FGD) (10)

Premarket Exempt

Yes No

Clear

Enema Kit: Empty Enema Bag Delivery System - 10815112020825 Catalog Number : 900303

Device Description : Empty Snap Cap Bag

Device Class : 2

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : FGD

Prescription Use : Yes

Device Count : 1

EXACTA l Screw Cap Bag: Empty Enema Bag Delivery System - 10815112020832 Catalog Number : 900304

Device Description : Empty Exacta l Bag

Device Class :

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : FGD

Prescription Use : Yes

Device Count : 1

"Y" Connector with Tubing - 10815112020856 Catalog Number : 900402

Device Description : Y Connector

Device Class : 2

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : FGD

Prescription Use : Yes

Device Count : 1

Remote Blue Air Bulb Insufflator Air Insufflation of Colon - 10815112020863 Catalog Number : 900403

Device Description : Remote Air Insufflator

Device Class :

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : FGD

Prescription Use : Yes

Device Count : 1

Blue Air Bulb Insufflator - 10815112020870 Catalog Number : 900404

Device Description : Air Bulb Insufflator

Device Class :

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : FGD

Prescription Use : Yes

Device Count : 12

Retention Cuff Inflator - 10815112020887 Catalog Number : 900405

Device Description : One Shot Cuff Inflator

Device Class :

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : FGD

Prescription Use : Yes

Device Count : 12

Flexi Air Tip XL - 10815112020894 Catalog Number : 900909

Device Description : XL Miller Air Tip

Device Class :

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : FGD

Prescription Use : Yes

Device Count : 12

SaftiCuff DK - 10815112020900 Catalog Number : 900910

Device Description : Safticuff DL Airway

Device Class : 2

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : FGD

Prescription Use : Yes

Device Count : 1

Safti Cuff - 10815112020917 Catalog Number : 900911

Device Description : Safticuff SL Airway

Device Class : 2

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : FGD

Prescription Use : Yes

Device Count : 1

Enema Ring: Fluid Collection Device - 10815112020955 Catalog Number : 901101

Device Description : Barium Enema Ring

Device Class : 2

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : FGD

Prescription Use : Yes

Device Count : 1

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