FDA UDI
In Commercial Distribution
🇺🇸 United States
Tandem Mobi Starter Kit
DI: 00389152408170
·
Model: 1014081
·
Tandem Diabetes Care, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tandem Mobi Starter Kit
- Primary DI
- 00389152408170
- Version / Model
- 1014081
- Company Name
- Tandem Diabetes Care, Inc.
- Labeler DUNS
- 827900809
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-21
- Public Version
- 1
- Public Version Date
- 2024-07-01
- Public Version Status
- New
- Public Device Record Key
- c156d015-3691-443a-8a56-4bf34ae79b29
Device Description
with Control-IQ 7.X
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 |
| QJI | Interoperable Automated Glycemic Controller | Clinical Chemistry | 862.1356 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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 | 00389152408170 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223213 | 000 |