FDA UDI
In Commercial Distribution
🇺🇸 United States
t:slim X2 5.0 Insulin Pump
DI: 00853052007271
·
Model: 1000891
·
Tandem Diabetes Care, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- t:slim X2 5.0 Insulin Pump
- Primary DI
- 00853052007271
- Version / Model
- 1000891
- Company Name
- Tandem Diabetes Care, Inc.
- Labeler DUNS
- 827900809
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-28
- Public Version
- 4
- Public Version Date
- 2023-05-04
- Public Version Status
- Update
- Public Device Record Key
- 42230a58-0890-4323-a178-d1ad441d5ea8
Device Description
t:slim X2 5.0 Insulin Pump, 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 |
|---|---|---|---|---|
| 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 | 00853052007271 | GS1 |
Customer Contacts
- Phone
- 877-801-6901
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P140015 | 000 |
| P140015 | 020 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit