FDA UDI
In Commercial Distribution
🇺🇸 United States
Omnipod 5 Pod
DI: 10385083000114
·
Model: POD-BLE-H1-520
·
Insulet Corporation
Product Codes
2
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
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Basic Information
- Brand Name
- Omnipod 5 Pod
- Primary DI
- 10385083000114
- Version / Model
- POD-BLE-H1-520
- Company Name
- Insulet Corporation
- Labeler DUNS
- 051334402
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-25
- Public Version
- 6
- Public Version Date
- 2025-12-04
- Public Version Status
- Update
- Public Device Record Key
- 83f9e052-d144-4469-8ea5-c1bc6b9937e5
Device Description
Omnipod 5 Pod
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10385083000213 | GS1 | 5 Pack Box | 5 | Not in Commercial Distribution | 2025-12-01 |
| Primary | 10385083000114 | GS1 | ||||
| Package | 10385083000138 | GS1 | 10 Pack Box | 10 | Not in Commercial Distribution | 2025-12-01 |
| Package | 20385083000210 | GS1 | 5 Pack Box | 5 | In Commercial Distribution | |
| Package | 20385083000135 | GS1 | 10 Pack Box | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-591-3455
- [email protected]