FLEXI-STOME Nipple Colostomy Tip 901307

GUDID 30815112021055

Nipple Colostomy Tip

BRACCO DIAGNOSTICS INC

Enema tip, single-use

• Primary Device ID: 30815112021055
• NIH Device Record Key: 64532662-8215-49b5-a0ba-700d66797464
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLEXI-STOME Nipple Colostomy Tip
• Version Model Number: 901307
• Catalog Number: 901307
• Company DUNS: 849234661
• Company Name: BRACCO DIAGNOSTICS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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
• Phone: 609-514-2200
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815112021051 [Primary]
GS1	30815112021055 [Package]; Contains: 10815112021051; Package: Box [12 Units]; In Commercial Distribution

FDA Product Code

• FGD: Catheter, Retention, Barium Enema With Bag

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-22
• Device Publish Date: 2016-09-19

Devices Manufactured by BRACCO DIAGNOSTICS INC

• 30815112021390 - CardioGen-82 Infusion System Model 1700: 2023-12-11 Infusion system for Rubidium-82 saline injection.
• 30815112021352 - CardioGen Patient Administration Set: 2023-10-24 Patient Administration Set for use with CardioGen-82 Infusion System
• 30815112021369 - Vented Cap for Waste Bottle: 2023-10-24 Vented Cap for Waste Bottle for use with CardioGen-82 Infusion System
• 30815112021376 - Waste Bottle: 2023-10-24 Waste Bottle for use with CardioGen-82 Infusion System
• 30815112021239 - Protocol Touch Colon Insufflator: 2023-09-08 Protocol Touch Colon Insufflator
• 30815112021253 - DIN 477 High Pressure Hose for CO2: 2023-09-08 DIN Connector
• 30815112021291 - High Pressure Hose and Yoke: 2023-09-08 High Pressure Hose and Yoke
• 10815112020016 - Fluid Administration Set: 2023-07-28 Large Bore Tubing Administration Set