MyCare Psychiatry

Basic Information

• Brand Name: MyCare Psychiatry
• Primary DI: 00894354002229
• Version / Model: MCP2-CON
• Catalog Number: MCP2-CON
• Company Name: SALADAX BIOMEDICAL, INC.
• Labeler DUNS: 144379539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-27
• Public Version: 1
• Public Version Date: 2022-02-04
• Public Version Status: New
• Public Device Record Key: 68a9c7de-a03e-4f62-98c1-c60706c082fc

Device Description

Control Kit 2

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LAS	Drug Specific Control Materials	Clinical Toxicology	862.3280	1

GMDN Terms

Code	Name	Definition	Implantable	Status
55560	Clozapine IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of clozapine in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00894354002229	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius