HYDRODEBRIDER®

GUDID 00763000089597

CONSOLE 1913001 HYDRODEBRIDER

MEDTRONIC XOMED, INC.

Nasal lavage system

• Primary Device ID: 00763000089597
• NIH Device Record Key: bd028a77-8803-4ee6-87a7-70762433f21e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HYDRODEBRIDER®
• Version Model Number: 1913001
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000089597 [Primary]

FDA Product Code

• KMA: IRRIGATOR, POWERED NASAL

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-06-11
• Device Publish Date: 2018-05-11

On-Brand Devices [HYDRODEBRIDER®]

• 00613994712608: HANDPIECE 1921002 HYDRODEBRID FRNTL ROHS
• 00613994233332: HYDRODEBRIDER 1914001 STANDARD HANDPIECE
• 00613994233295: CONSOLE 1913001 HYDRODEBRIDER
• 00643169376106: HYDRODEBRIDER 1914001 STD HANDPIECE ROHS
• 00643169360877: CONSOLE 1913001 HYDRODEBRIDER ROHS
• 00763000089597: CONSOLE 1913001 HYDRODEBRIDER