Magnesium 20737593322

GUDID 04015630913381

Roche Diagnostics GmbH

Magnesium (Mg2+) IVD, kit, spectrophotometry

• Primary Device ID: 04015630913381
• NIH Device Record Key: 9893e436-e69c-412a-8572-12b9981b39d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Magnesium
• Version Model Number: 20737593322
• Catalog Number: 20737593322
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630913381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954992

FDA Product Code

• JGJ: PHOTOMETRIC METHOD, MAGNESIUM

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: 2021-02-16
• Device Publish Date: 2021-02-08

On-Brand Devices [Magnesium]

• 04015630926992: 5401712190
• 04015630913381: 20737593322