t:slim X2 5.x Insulin Pump, Replacement, Refurbished
t:slim X2 5.x Insulin Pump - 1003808
Device Description
An assembly of battery-powered portable devices designed to deliver insulin and to measure blood glucose as an aid in the management of diabetes mellitus for a patient requiring insulin. It consists of a portable electronic insulin pump that provides continuous subcutaneous delivery of insulin at set and variable rates, and a wireless microprocessor remote controller that interfaces with the pump to control pump functions and receive pump status information. The controller also incorporates a blood glucose meter and built-in test strip port for the quantitative measurement of glucose in fresh capillary blood.
Environmental Conditions
- 140.00
- -4.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
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: 00853052007981
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