PreciseDose Dispenser

Basic Information

• Brand Name: PreciseDose Dispenser
• Primary DI: 00338779815014
• Version / Model: 8150-01
• Catalog Number: 8150-01
• Company Name: Medisca Inc.
• Labeler DUNS: 794301960
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2023-05-11
• Public Version: 1
• Public Version Date: 2023-05-19
• Public Version Status: New
• Public Device Record Key: 54072a52-b1c5-49bb-af95-b55b14de600a

Device Description

Syringe, PreciseDose Dispenser Amber, 10mL, w/Tip cap

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• 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
KYX	Dispenser, Liquid Medication	General Hospital	880.6430	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64558	Oral/enteral medicine medicated administration kit, reusable	A collection of devices with an included pharmaceutical intended to be used for the oral and/or enteral administration of an accurate dosage of the included medication. In addition to the pharmaceutical, it will include a dose measuring and/or dispensing device(s) such as a calibrated syringe, medicine cup, or spoon, and may include appropriate accessories (e.g., cap, bottle adaptor). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10338779815011	GS1
Primary	00338779815014	GS1