FDA UDI
In Commercial Distribution
🇺🇸 United States
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM
DI: 00852162004408
·
Model: 006194
·
Tandem Diabetes Care, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM
- Primary DI
- 00852162004408
- Version / Model
- 006194
- Company Name
- Tandem Diabetes Care, Inc.
- Labeler DUNS
- 827900809
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-15
- Public Version
- 4
- Public Version Date
- 2023-05-04
- Public Version Status
- Update
- Public Device Record Key
- 88428bbf-16ac-418d-b123-45d0e686a814
Device Description
The #1-rated insulin pump is now integrated with the #1-rated Continuous Glucose Monitoring brand that set the standard for accuracy and performance in sensor-augmented pumps. The t:slim G4 Pump is the only pump that conveniently combines CGM graphs and trend information with current insulin delivery together on a single color touch screen to help you make more informed decisions.
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 | 00852162004408 | GS1 |
Customer Contacts
- Phone
- 877-801-6901
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P140015 | 000 |
| P140015 | 007 |
| P140015 | 008 |
| P140015 | 010 |
| P140015 | 011 |
| P140015 | 012 |
| P140015 | 015 |
| P140015 | 016 |
| P140015 | 018 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit