Protocol Administration Set With Flexi-Cuff Retention Tip 390401

GUDID 30815112021574

Protocol Administration Set With Flexi-Cuff Retention Tip CO2 Delivery System for Colon Insufflation

Bracco Diagnostics Inc.

Insufflation gas conditioning tubing set

• Primary Device ID: 30815112021574
• NIH Device Record Key: 1841edff-b998-449c-9636-dc654987325a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Protocol Administration Set With Flexi-Cuff Retention Tip
• Version Model Number: 390401
• Catalog Number: 390401
• Company DUNS: 849234661
• Company Name: Bracco Diagnostics Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx
• Phone: 609-514-2200
• Email: xx@xx.xx

Device Dimensions

• Catheter Gauge: 48 French
• Catheter Gauge: 48 French
• Catheter Gauge: 48 French
• Catheter Gauge: 48 French
• Catheter Gauge: 48 French
• Catheter Gauge: 48 French
• Catheter Gauge: 48 French
• Catheter Gauge: 48 French
• Catheter Gauge: 48 French
• Catheter Gauge: 48 French
• Catheter Gauge: 48 French
• Catheter Gauge: 48 French
• Catheter Gauge: 48 French
• Catheter Gauge: 48 French
• Catheter Gauge: 48 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815112021570 [Primary]
GS1	30815112021574 [Package]; Contains: 10815112021570; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030854

FDA Product Code

• FCX: Insufflator, Automatic Carbon-Dioxide For Endoscope

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-26
• Device Publish Date: 2025-05-16

Devices Manufactured by Bracco Diagnostics Inc.

• 00815112021535 - Junior Flexi Tip Pediatric Enema Tip: 2025-06-09 Junior Flexi Tip
• 10815112021556 - SaftiCuff DK: 2025-06-09 Safticuff DL Airway
• 10815112021563 - Super XL Enema System: 2025-06-09 SXL w/Att. (Silicone Cuff)
• 30815112021581 - Enema Kit: Empty Enema Bag Delivery System: 2025-06-09 Empty Snap Cap Bag
• 10815112021594 - EXACTA l Screw Cap Bag: Empty Enema Bag Delivery System: 2025-06-09 Empty Exacta l Bag
• 10815112021624 - 24 Fr Infant Flexi Tip: Pediatric Enema Tip: 2025-06-09 Infant Flexi Tip
• 30815112021635 - Miller Enema Air Tip: Without Retention Cuff: 2025-06-09 Miller Air Tip
• 00815112021641 - 14 French Pediatric Flexi Tip: 2025-06-09 14 Fr Pediatric Flexi Tip