t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM, Replacement

Basic Information

• Brand Name: t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM, Replacement
• Primary DI: 00852162004439
• Version / Model: 007829
• Catalog Number: 007829
• Company Name: Tandem Diabetes Care, Inc.
• Labeler DUNS: 827900809
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-03-25
• Public Version: 4
• Public Version Date: 2023-05-04
• Public Version Status: Update
• Public Device Record Key: 91292a26-998d-4f5d-a8f4-7f0ff8a226c6

Device Description

A replacement t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM.

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
OYC	Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor	Unknown		3

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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852162004439	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P140015	000
P140015	006
P140015	007
P140015	008
P140015	009
P140015	010
P140015	011
P140015	012
P140015	015
P140015	016
P140015	018

Storage Conditions

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