Protocol Colon Insufflator Demo Unit 390302

GUDID 30815112021130

Protocol Colon Insuff Demo

Bracco Diagnostics Inc.

Gastrointestinal endoscopic insufflator
Primary Device ID30815112021130
NIH Device Record Key756e3d7b-e2a9-4f37-9ee3-634b3aafeb80
Commercial Distribution StatusIn Commercial Distribution
Brand NameProtocol Colon Insufflator Demo Unit
Version Model Number390302
Catalog Number390302
Company DUNS849234661
Company NameBracco Diagnostics Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110815112021136 [Primary]
GS130815112021130 [Package]
Contains: 10815112021136
Package: Box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FCXInsufflator, Automatic Carbon-Dioxide For Endoscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2025-05-26
Device Publish Date2016-09-19

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10815112021563 - Super XL Enema System2025-06-09 SXL w/Att. (Silicone Cuff)
30815112021581 - Enema Kit: Empty Enema Bag Delivery System2025-06-09 Empty Snap Cap Bag
10815112021594 - EXACTA l Screw Cap Bag: Empty Enema Bag Delivery System2025-06-09 Empty Exacta l Bag
10815112021624 - 24 Fr Infant Flexi Tip: Pediatric Enema Tip2025-06-09 Infant Flexi Tip
30815112021635 - Miller Enema Air Tip: Without Retention Cuff2025-06-09 Miller Air Tip
00815112021641 - 14 French Pediatric Flexi Tip2025-06-09 14 Fr Pediatric Flexi Tip

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