Protocol Administration Set With Flexi-Cuff Retention Tip 390401

GUDID 10815112020160

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: 10815112020160
• NIH Device Record Key: 56781b1b-ccdb-42f8-abd8-b8919ebe00bd
• 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

Device Dimensions

• Catheter Gauge: 48 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815112020160 [Primary]
GS1	30815112020164 [Package]; Package: Box [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-06-30
• Device Publish Date: 2016-09-19

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