High Pressure Hose and Yoke 710603

GUDID 30815112020799

High Pressure Hose and Yoke

BRACCO DIAGNOSTICS INC

Gastrointestinal endoscopic insufflator

• Primary Device ID: 30815112020799
• NIH Device Record Key: 863eebcf-bb85-4a18-949c-09eb1b1158e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: High Pressure Hose and Yoke
• Version Model Number: 710603
• Catalog Number: 710603
• Company DUNS: 849234661
• Company Name: BRACCO DIAGNOSTICS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	30815112020799 [Primary]

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

On-Brand Devices [High Pressure Hose and Yoke]

• 30815112020799: High Pressure Hose and Yoke
• 30815112021291: High Pressure Hose and Yoke