Enteroclysis Catheter 13Fx155cm 901501

GUDID 50815112021097

Enteroclysis Cath 13F w/Ball

BRACCO DIAGNOSTICS INC

Barium enema kit

• Primary Device ID: 50815112021097
• NIH Device Record Key: 953b5dca-38fa-4aa6-8c9c-0c75d6d82c8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enteroclysis Catheter 13Fx155cm
• Version Model Number: 901501
• Catalog Number: 901501
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• 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
• 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
• 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	30815112021093 [Primary]
GS1	50815112021097 [Package]; Contains: 30815112021093; Package: Box [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K911349

FDA Product Code

• EZK: Catheter, Retention Type

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• 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