LeadCare® II Replacement AC Adapter and Plug Set

Basic Information

• Brand Name: LeadCare® II Replacement AC Adapter and Plug Set
• Primary DI: 00850355006123
• Version / Model: LeadCare® II
• Catalog Number: 82-0001
• Company Name: MAGELLAN DIAGNOSTICS, INC.
• Labeler DUNS: 078525694
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 16747fe1-c01a-46d1-ad1a-9a106ee7b2c0

Device Description

LeadCare® II Replacement AC Adapter and Plug Set

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DOF	Lead, Atomic Absorption	Clinical Toxicology	862.3550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31646	Lead (Pb) analyser IVD	An electrically-powered laboratory instrument intended to be used for the quantitative determination of the heavy metal lead (Pb) in a clinical specimen, using technology which may incorporate fluorometry or electrometry. The analyser requires the use of specific reagents and test strips, packaged together in a test kit. The analyser is intended to be used by health professionals at the point-of-care, and often also in the laboratory.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850355006123	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K052549	000