FDA UDI
In Commercial Distribution
🇺🇸 United States
Omnipod Go Insulin Delivery Device 40U/day
DI: 10385084000403
·
Model: POD-INS-I1-4025
·
INSULET CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Omnipod Go Insulin Delivery Device 40U/day
- Primary DI
- 10385084000403
- Version / Model
- POD-INS-I1-4025
- Company Name
- INSULET CORPORATION
- Labeler DUNS
- 051334402
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-18
- Public Version
- 1
- Public Version Date
- 2023-08-28
- Public Version Status
- New
- Public Device Record Key
- a9266d86-bbd4-4fc4-8a05-759fd07ccc45
Device Description
Omnipod Go Insulin Delivery Device 40U/day
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 |
|---|---|---|---|---|
| LZG | Pump, Infusion, Insulin | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63803 | Ambulatory insulin infusion pump/administration unit | A badge-like, battery-powered, disposable device designed to adhere to skin or clothing (e.g., with a pressure-sensitive adhesive) to provide basal and/or periodic bolus subcutaneous delivery of insulin to a patient with diabetes mellitus. The device integrates an electromechanical pumping unit, an insulin reservoir filled by the patient, and an administration cannula/needle; it is patient operated with the use of integral controls or a remote control unit (not included). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20385084000400 | GS1 | 5 Pack Box | 5 | In Commercial Distribution | |
| Primary | 10385084000403 | GS1 |
Customer Contacts
- Phone
- 1800-591-3455
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223372 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 86 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 700 – 1060 KiloPascal