Sodium electrode 10825468001

GUDID 07613336227763

Roche Diagnostics GmbH

Sodium (Na+) electrode IVD

• Primary Device ID: 07613336227763
• NIH Device Record Key: b56bb430-cbf8-480e-9df0-85c796c6f854
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sodium electrode
• Version Model Number: 10825468001
• Catalog Number: 10825468001
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• 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: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336227763 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060373

FDA Product Code

• JGS: ELECTRODE, ION SPECIFIC, SODIUM

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: 2025-03-13
• Device Publish Date: 2025-03-05

On-Brand Devices [Sodium electrode]

• 04015630014286: 03111598180
• 07613336227763: 10825468001