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UTC 3ml Medication Cartridge

FDA UDI

Class II (US FDA UDI)

by Gilero, Inc

Identity

Trade Name
UTC 3ml Medication Cartridge FDA UDI
Generic Name
Infusion pump cassette FDA UDI
Device Name
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 FDA UDI
Model / Reference
11949-325-09 FDA UDI
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 FDA UDI

Identifiers

Catalog Number
11949-325-09 FDA UDI
Primary DI / UDI-DI
00850025535502 FDA UDI
FDA Product Code
MRZ FDA UDI
GMDN Term
Infusion pump cassette FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5725 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Infusion pump cassette

UTC 3ml Medication Cartridge by Gilero, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Infusion pump cassette.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gilero, Inc

Sources (1)

  • FDA UDI 63c4633d-2dbf-4139-a432-755c80763d9a 34 fields · synced May 30, 2026