FDA UDI
In Commercial Distribution
🇺🇸 United States
Omnipod DASH PDM
DI: 10385082000009
·
Model: PDM-USA1-D001-MG-USA1
·
Insulet Corporation
Product Codes
3
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Omnipod DASH PDM
- Primary DI
- 10385082000009
- Version / Model
- PDM-USA1-D001-MG-USA1
- Company Name
- Insulet Corporation
- Labeler DUNS
- 051334402
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-25
- Public Version
- 3
- Public Version Date
- 2025-12-04
- Public Version Status
- Update
- Public Device Record Key
- cd3ecb07-6694-45c4-99da-8c83dcb30663
Device Description
Omnipod DASH Personal Diabetes Manager (PDM) mg/dL
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 |
|---|---|---|---|---|
| 63866 | Ambulatory insulin infusion administration unit/remote control system | An assembly of devices intended to provide remotely-controlled basal and/or periodic bolus subcutaneous delivery of insulin to a patient with diabetes mellitus. It consists of a badge-like, battery-powered, disposable device (electromechanical pumping unit, an insulin reservoir filled by the patient, and an administration cannula/needle) designed to adhere to skin or clothing (e.g., with a pressure-sensitive adhesive), and a wireless unit with dedicated software that interfaces with the pump to control and program pump functions and receive pump status information. The remote control may be capable of data transmission to other platforms. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10385082000009 | GS1 | ||||
| Package | 10385082000542 | GS1 | Kit | 1 | In Commercial Distribution | |
| Package | 10385081140010 | GS1 | Pharmacy Kit | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-591-3455
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211575 | 000 |