LeadCare® Plus Blood Lead Analyzer Kit 82-0001

GUDID 00850355006062

LeadCare® Plus Blood Lead Analyzer Kit

MAGELLAN DIAGNOSTICS, INC.

Lead (Pb) analyser IVD

• Primary Device ID: 00850355006062
• NIH Device Record Key: 16b40567-8339-46f0-850f-442d72133d46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LeadCare® Plus Blood Lead Analyzer Kit
• Version Model Number: LeadCare® Plus
• Catalog Number: 82-0001
• Company DUNS: 078525694
• Company Name: MAGELLAN DIAGNOSTICS, INC.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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: 800-275-0102
• Email: LeadCareSupport@magellandx.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850355006062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142705

FDA Product Code

• DOF: Lead, Atomic Absorption

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: 2016-09-19

On-Brand Devices [LeadCare® Plus Blood Lead Analyzer Kit]

• 00850355006185: LeadCare® Plus Blood Lead Analyzer Kit Refurbished
• 00850355006062: LeadCare® Plus Blood Lead Analyzer Kit