Enteroclysis Catheter 13Fx155cm 901501

GUDID 50815112021097

Enteroclysis Cath 13F w/Ball

BRACCO DIAGNOSTICS INC

Barium enema kit Barium enema kit Barium enema catheter Barium enema catheter Barium enema catheter Barium enema catheter Barium enema catheter Barium enema catheter Barium enema catheter Barium enema catheter Barium enema catheter Barium enema catheter Barium enema catheter Barium enema catheter Barium enema catheter Barium enema catheter Barium enema catheter Barium enema catheter Barium enema catheter

• 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

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

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