UTC 3ml Medication Cartridge

Basic Information

• Brand Name: UTC 3ml Medication Cartridge
• Primary DI: 00850025535502
• Version / Model: 11949-325-09
• Catalog Number: 11949-325-09
• Company Name: Gilero, LLC
• Labeler DUNS: 158233937
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-25
• Public Version: 1
• Public Version Date: 2023-10-03
• Public Version Status: New
• Public Device Record Key: 63c4633d-2dbf-4139-a432-755c80763d9a

Device Description

UTC 3mL Medication Cartridge: The UTC 3 mL Medication Cartridge is intended for use in hospital and outpatient care environments with the CADD-MS®3 Ambulatory Infusion Pump for subcutaneous infusion of medication in adults

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MRZ	Accessories, Pump, Infusion	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57791	Infusion pump cassette	A sterile device designed to be used in conjunction with an infusion pump or a device containing an infusion pump (e.g., a physiology-monitoring sedation system, physiology-monitoring anaesthesia system), for the delivery of an intravenous (IV) medication (e.g., a sedative or anaesthetic) contained within an independent drug vial. The cassette is inserted into the infusion pump and the drug vial is inserted into the cassette; the cassette tubing interfaces with the pump drive mechanism for medication delivery through connection with an infusion administration set. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850025535502	GS1
Package	10850025535509	GS1	Carton	25	In Commercial Distribution
Package	20850025535506	GS1	Shipper	60	In Commercial Distribution