HYDROCLEANSE™

GUDID 00643169864429

DEVICE 1960100 SINUS WASH SYSTEM

MEDTRONIC XOMED, INC.

Nasal irrigation set, clinical

• Primary Device ID: 00643169864429
• NIH Device Record Key: 689f482c-94bb-42c3-a5ca-57f8bc2e5c8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HYDROCLEANSE™
• Version Model Number: 1960100
• 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: true
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169864429 [Primary]

FDA Product Code

• KAR: IRRIGATOR, SINUS

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-10
• Device Publish Date: 2018-08-09

Devices Manufactured by MEDTRONIC XOMED, INC.

• 20763000888989 - Merocel: 2026-03-16 SPONGE 400515 10PK KENNEDY INTRANASAL
• 20763000888996 - Merocel: 2026-03-16 PACKING 440412 MEROCEL 10PK DOYLE NASAL
• 00763000892951 - M4: 2026-03-09 MICRODEBRIDER 1898200T IGS M4 ROHS
• 00199150023851 - N/A: 2026-02-24 PROBE 8225101E PRASS STD PROT HANDLE
• 00199150023868 - N/A: 2026-02-24 PROBE 8225101 5PK PRASS STD PROT HANDLE
• 00199150023875 - N/A: 2026-02-24 PROBE 8225110 10PK PRASS STD
• 00199150023882 - N/A: 2026-02-24 PROBE 8225103 5PK PRASS SLIM PROT HANDLE
• 00763000548797 - Hydrodebrider: 2026-02-23 HYDRODEBRIDER 1914001 STD HANDPIECE ROHS