Thermo Scientific Infinity™ for Beckman Coulter SYNCHRON Systems

GUDID 00845275005424

Fisher Diagnostics

Lithium therapeutic drug monitoring IVD, reagent

• Primary Device ID: 00845275005424
• NIH Device Record Key: 6a334392-2aac-4897-8172-3994f399fb61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermo Scientific Infinity™ for Beckman Coulter SYNCHRON Systems
• Version Model Number: A19611
• Company DUNS: 183998769
• Company Name: Fisher Diagnostics
• Device Count: 5
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-528-0494
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845275005424 [Primary]
GS1	00845275006520 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003583

FDA Product Code

• NDW: Assay, Porphyrin, Spectrophotometry, Lithium

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [Thermo Scientific Infinity™ for Beckman Coulter SYNCHRON Systems]

• 00845275005424: A19611
• 00845275005417: OL66001
• 00845275005400: OL60101