t:slim X2 Insulin Pump with Control-IQ

Basic Information

• Brand Name: t:slim X2 Insulin Pump with Control-IQ
• Primary DI: 00389152000107
• Version / Model: 1009643
• Catalog Number: 1010012
• Company Name: Tandem Diabetes Care, Inc.
• Labeler DUNS: 827900809
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-15
• Public Version: 2
• Public Version Date: 2023-05-04
• Public Version Status: Update
• Public Device Record Key: 47ba2e0e-ce07-4885-9a0e-eedab793d906

Device Description

t:slim X2 Insulin Pump with Control-IQ, 7.6.x, Refurbished Replacement

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	880.5730	2
QJS	Interoperable Automated Glycemic Controller, Insulin Suspend	Clinical Chemistry	862.1356	2
NDC	Calculator, Drug Dose	Anesthesiology	868.1890	2

GMDN Terms

Code	Name	Definition	Implantable	Status
51083	Ambulatory insulin infusion pump/blood glucose analyser system	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.	No	Active
60770	Ambulatory insulin infusion pump/interstitial glucose monitoring system	An assembly of portable devices intended to simultaneously continuously monitor interstitial glucose levels and subcutaneously infuse insulin in patients with diabetes. Sometimes referred to as a closed loop artificial pancreas, it consists of a percutaneous blood glucose monitoring system (CGM), an ambulatory insulin infusion pump, and software on a dedicated handset or transmitter capable of telemetric communication with the other components. The software contains an algorithm to allow continuous communication between the two devices, and may enable the manual input of data with respect to meals and physical activity.	No	Active
63389	Ambulatory insulin infusion pump cartridge filling device, manual	A manually-operated device designed to fill a cartridge/reservoir, used in an electronic ambulatory insulin infusion pump, with insulin from an insulin vial through a manual mechanism. It is typically a plunger-like housing into which an insulin cartridge is placed and to which an insulin vial is connected for the transfer of insulin upon manual pushing of the plunger. The device is intended to be operated by laypersons and healthcare providers. This is a reusable device.	No	Active
35838	Ambulatory insulin infusion pump reservoir	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.	No	Active
64891	Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm	A portable electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus, incorporating software to receive glucose status data from a monitor/transmitter and to determine the delivery of insulin based on a continuous scalar algorithm. It may be badge-like, designed to adhere to skin or clothing or worn in a case attached to the belt or carried in a pocket and includes a reservoir, a pumping mechanism, and an infusion-rate controller. It may also allow additional manual administration/infusion and functionality to send data to a remote reporting system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00389152000107	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit