UTC 3ml Medication Cartridge 11949-325-09

GUDID 00850025535502

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

Gilero, LLC

Infusion pump cassette

• Primary Device ID: 00850025535502
• NIH Device Record Key: 63c4633d-2dbf-4139-a432-755c80763d9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UTC 3ml Medication Cartridge
• Version Model Number: 11949-325-09
• Catalog Number: 11949-325-09
• Company DUNS: 158233937
• Company Name: Gilero, LLC
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850025535502 [Primary]
GS1	10850025535509 [Package]; Package: Carton [25 Units]; In Commercial Distribution
GS1	20850025535506 [Package]; Contains: 10850025535509; Package: Shipper [60 Units]; In Commercial Distribution

FDA Product Code

• MRZ: Accessories, Pump, Infusion

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-03
• Device Publish Date: 2023-09-25

Devices Manufactured by Gilero, LLC

• 00382902001003 - BD SmartSite Bag 100mL: 2023-12-11 The SmartSite Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular a
• 50382902002500 - BD SmartSite Bag 250mL: 2023-12-11 The SmartSite Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular a
• 50382902005006 - BD SmartSite Bag 500mL: 2023-12-11 The SmartSite Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular a
• 00850025535502 - UTC 3ml Medication Cartridge: 2023-10-03UTC 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
• 00850025535502 - UTC 3ml Medication Cartridge: 2023-10-03 UTC 3mL Medication Cartridge: The UTC 3 mL Medication Cartridge is intended for use in hospital and outpatient care environments
• 00850025535991 - NUM Vapocoolant: 2021-06-14 NUM is a sterile topical anesthetic spray – vapocoolant (skin refrigerant) intended for topical application to control pain as