FDA UDI
In Commercial Distribution
🇺🇸 United States
Omnipod
DI: 10385081140003
·
Model: UST400
·
INSULET CORPORATION
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Omnipod
- Primary DI
- 10385081140003
- Version / Model
- UST400
- Catalog Number
- 14500-5A
- Company Name
- INSULET CORPORATION
- Labeler DUNS
- 051334402
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-09-12
- Public Version Status
- Update
- Public Device Record Key
- 49436ff9-b4d6-4b7e-96e4-df70deed240c
Device Description
Eros PDM(Personal Diabetes Manager)
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
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | 862.1345 | 2 |
| LZG | Pump, Infusion, Insulin | General Hospital | 880.5725 | 2 |
| NDC | Calculator, Drug Dose | Anesthesiology | 868.1890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35983 | Ambulatory insulin infusion pump, electronic | A portable, battery-powered, electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus. It may be badge-like, designed to adhere to skin or clothing (e.g., with a pressure-sensitive adhesive), or worn in a case attached to the belt or carried in a pocket. It includes a reservoir (e.g., a cartridge similar to a syringe), a pumping mechanism, and an infusion-rate controller. The pump infuses microvolume pulses and/or bolus doses of insulin subcutaneously, typically into the abdomen, through a needle or catheter (not included). | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10385081140003 | GS1 | ||||
| Package | 20385081140000 | GS1 | Starter Kit | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 8005913455
- [email protected]