FDA.reportPublic FDA data

UTC 3ml Medication Cartridge

Primary DI
00850025535502
Brand
UTC 3ml Medication Cartridge
Company
Gilero, LLC
Model
11949-325-09
Catalog number
11949-325-09
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
Published
2023-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MRZAccessories, Pump, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRZAccessories, Pump, InfusionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850025535509PackageGS125In Commercial Distribution
20850025535506PackageGS160In Commercial Distribution
00850025535502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002553550910850025535509
2085002553550620850025535506
00850025535502008500255355028500255355020850025535502

GMDN Terms#

Term, Definition table
TermDefinition
Infusion pump cassetteA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
158233937
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382902002505BD SmartSite Bag 250mL11365-325-192002502023-12-01
00382902005001BD SmartSite Bag 500mL11365-325-042005002023-12-01
00382902001003BD SmartSite Bag 100mL11365-325-182001002023-12-01
50382902002500BD SmartSite Bag 250mL11365-325-192002502023-12-01
50382902005006BD SmartSite Bag 500mL11365-325-042005002023-12-01
00850025535991NUM VapocoolantNS01B2021-06-04

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Primary DI, Brand, Company table
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