DIN 477 High Pressure Hose for CO2 390513

GUDID 30815112021710

DIN Connector

Bracco Diagnostics Inc.

Gastrointestinal endoscopic insufflator
Primary Device ID30815112021710
NIH Device Record Key05a7cb09-5a92-4271-b90a-7b52661c9d04
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIN 477 High Pressure Hose for CO2
Version Model Number390513
Catalog Number390513
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 Batchtrue
Serial Numberfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS130815112021710 [Primary]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-08
Device Publish Date2025-06-30

Devices Manufactured by Bracco Diagnostics Inc.

30815112021703 - Two Tank Shuttle Valve System2025-07-08 Two Tank Shuttle Valve System
30815112021710 - DIN 477 High Pressure Hose for CO22025-07-08DIN Connector
30815112021710 - DIN 477 High Pressure Hose for CO22025-07-08 DIN Connector
00815112021535 - Junior Flexi Tip Pediatric Enema Tip2025-06-09 Junior Flexi Tip
10815112021556 - SaftiCuff DK2025-06-09 Safticuff DL Airway
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

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