- Physicians Office Resource

t:slim G4 / X2 Cartridge, t:lock, 2 Pack
t:slim X2 Cartridge, t:lock, 2 Pack - 1000728

Device Description

An insulin-filled receptacle (e.g., a cartridge similar to a syringe) intended to be used together with a body-worn insulin pump for the delivery of patient-controlled amounts of insulin to an ambulatory diabetic. This is a single-use device.

Environmental Conditions

Storage Environment Humidity - Percent (%) Relative Humidity

90.00
20.00

Storage Environment Temperature - Degrees Fahrenheit

140.00
-4.00

Device Sizes

Total Volume: 3 Milliliter

Total Volume: 3 Milliliter

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: OYC

Device Name: Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

Device Class: 3

Physical State: Must include product code MDS, sensor, invasive test system, or product code PQF, sensor, glucose, invasive, non-adjunctive.

Definition: The insulin pump is intended to be used as a component of an invasive glucose device. The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the mangement of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor.

Submission Type ID: 2

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the mangement of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: see indications for use

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Identifiers

Device Id: 00853052007233

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: 00853052007547

Device Type: Unit of Use

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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