Iron Gen.2 3183696122

GUDID 04015630918904

Roche Diagnostics GmbH

Iron IVD, kit, spectrophotometry

• Primary Device ID: 04015630918904
• NIH Device Record Key: 0f64b242-ea25-42fe-9fd9-88aae3ac4b27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Iron Gen.2
• Version Model Number: 3183696122
• Catalog Number: 3183696122
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• 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: 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	04015630918904 [Primary]

FDA Product Code

• JIY: Photometric method, iron (non-heme)

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: 2021-01-26
• Device Publish Date: 2021-01-18

On-Brand Devices [Iron Gen.2]

• 07613336121344: 08057931190
• 04015630925049: 5169291190
• 04015630918904: 3183696122
• 04015630926947: 05401658190
• 07613336226803: 10059605190