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Bracco Diagnostic, Inc.

Last updated May 23, 2026

What Bracco Diagnostic, Inc. makes

Bracco Diagnostic, Inc. makes medical devices such as endoscopic insufflators, including the CO2MPACT Endoscopic Insufflator and the PROTOCO, L Touch Colon Insufflator, as well as related accessories like the CO2 Endoscopic Insufflator In Line Tubing Set.

The company's portfolio is regulated as Class II devices and is listed in the FDA 510(k) registry, with the company based in the US.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What type of products does Bracco Diagnostic, Inc. manufacture?

Bracco Diagnostic, Inc. makes medical devices such as endoscopic insufflators and related accessories, as seen in their portfolio which includes the CO2MPACT Endoscopic Insufflator and the PROTOCO, L Touch Colon Insufflator.

Where is Bracco Diagnostic, Inc. based?

The company is based in the US, indicating its primary location of operation.

Which regulatory registries list Bracco Diagnostic, Inc.'s devices?

The company's devices are listed in the FDA 510(k) registry, which is a database of medical devices that have been cleared for marketing in the US.

How are Bracco Diagnostic, Inc.'s devices classified?

The company's devices are classified as Class II, which is a category of medical devices that are subject to more stringent regulatory controls than Class I devices but less than Class III devices.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
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EUDAMED SRN: —
FDA FEI Number: —
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Catalogue (108)

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Device	Model / Reference	Registries	Class	Status
Protocol Administration Set With Flexi-Cuff Retention Tip	390401	FDA UDI	Class II	Active
Accessory Package	001710	FDA UDI	Class II	Active
Enema Kit: Empty Enema Bag Delivery System	900303	FDA UDI	Class II	Active
Protocol Touch Colon Insufflator	390308	FDA UDI	Class II	Active
Tubing Clamp: Fits Standard 5/16' Tubing	900401	FDA UDI	Class II	Active
Protocol Colon Insufflator	390301	FDA UDI	Class II	Active
24 Fr Infant Flexi Tip: Pediatric Enema Tip	901303	FDA UDI	Class II	Active
SaftiCuff DK	900910	FDA UDI	Class II	Active
High Pressure Hose and Yoke	710603	FDA UDI	Class II	Active
High Pressure Hose and Yoke	710603	FDA UDI	Class II	Active
Protocol Administration Set With Flexi-Cuff Retention Tip	390401	FDA UDI	Class II	Active
24 Fr Infant Flexi Tip: Pediatric Enema Tip	901303	FDA UDI	Class II	Active
Elution Test Vial	001530	FDA UDI	Class I	Active
Retention Cuff Inflator	900405	FDA UDI	Class II	Active
FLEXI-STOME Cone Colostomy Tip	901306	FDA UDI	Class II	Active
Rounded Flexi Tip Adult Enema Tip	901301	FDA UDI	Class II	Active
Enteroclysis Catheter 13Fx155cm	901501	FDA UDI	Class II	Unknown
CardioGen Patient Administration Set	001506	FDA UDI	Class II	Active
Two Tank Shuttle Valve System	710602	FDA UDI	Class II	Active
Enema Kit: Empty Enema Bag Delivery System	900302	FDA UDI	Class II	Active
Junior Flexi Tip Pediatric Enema Tip	901309	FDA UDI	Class II	Active
FLEXI-STOME Cone Colostomy Tip	901306	FDA UDI	Class II	Active
"Y" Connector with Tubing	900402	FDA UDI	Class II	Active
E-Z-GEL UltraSound Gel	601004	FDA UDI	Class II	Active
DIN 477 High Pressure Hose for CO2	390513	FDA UDI	Class II	Active
Miller Enema Air Tip with Non-Latex Retention Cuff	901201	FDA UDI	Class II	Active
Elution Test Vial Shield	001550	FDA UDI	Class I	Active
18 French Pediatric Flexi Tip	901308	FDA UDI	Class II	Active
Miller Enema Air Tip: Without Retention Cuff	901304	FDA UDI	Class II	Active
Tubing Clamp: Fits Standard 5/16' Tubing	900401	FDA UDI	Class II	Active
Waste Bottle	001520	FDA UDI	Class I	Active
Blue Air Bulb Insufflator	900404	FDA UDI	Class II	Active
Remote Blue Air Bulb Insufflator Air Insufflation of Colon	900403	FDA UDI	Class II	Active
Enteroclysis Admin Kit	901403	FDA UDI	Class II	Unknown
Flexi Air Tip XL	900909	FDA UDI	Class II	Active
EXACTA l Screw Cap Bag: Empty Enema Bag Delivery System	900304	FDA UDI	Class II	Active
E-Z-GEL UltraSound Gel	601001	FDA UDI	Class II	Active
14 French Pediatric Flexi Tip	901305	FDA UDI	Class II	Active
E-Z-SCAN Low Viscosity UltraSound Gel	601003	FDA UDI	Class II	Active
Elution Test Vial	001730	FDA UDI	Class II	Active
XL Flexi Tip: Adult Enema Tip	901302	FDA UDI	Class II	Active
E-Z-GEL UltraSound Gel	601001	FDA UDI	Class II	Active
FLEXI-STOME Nipple Colostomy Tip	901307	FDA UDI	Class II	Active
14 French Pediatric Flexi Tip	901305	FDA UDI	Class II	Active
18 French Pediatric Flexi Tip	901308	FDA UDI	Class II	Active
SaftiCuff DK	900910	FDA UDI	Class II	Active
Protocol Accessory Cart	390305	FDA UDI	Class II	Active
CardioGen Patient Administration Set	001506	FDA UDI	Class II	Active
EXACTA l Screw Cap Bag: Empty Enema Bag Delivery System	900304	FDA UDI	Class II	Active
Fast Find Grid: Disposable CT Biopsy Grid	600001	FDA UDI	Class II	Active

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