The #1
t:slim G4 Cartridge 2 Pack - 007527
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
- 90.00
- 20.00
- 140.00
- -4.00
Device Sizes
- 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 IdentifiersDevice Id: 00852162004422
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: 10852162004412
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