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Omnipod Insulin Management System
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref ZXP420Model Omnipod Insulin Management System
Identity
- Trade Name
- Omnipod Insulin Management System EUDAMEDOmnipod FDA UDI
- Generic Name
- Ambulatory insulin infusion pump/blood glucose analyser system FDA UDI
- Device Name
- EROS Single Pod EUDAMEDEros Pod Insulin Pump. FDA UDI
- Model / Reference
- Omnipod Insulin Management System EUDAMEDZXP420 EUDAMEDFDA UDI
- Description
- Eros Pod Insulin Pump. FDA UDI
Identifiers
- Catalog Number
- 19191 FDA UDI
- Primary DI / UDI-DI
- 10385081120036 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10385081120036 EUDAMED
- FDA Product Code
- LZG FDA UDINBW FDA UDINDC FDA UDI
- EMDN Code
- Z120402160101 PORTABLE INSULIN MICROINFUSORS EUDAMED
- GMDN Term
- Ambulatory insulin infusion pump/blood glucose analyser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5725 FDA UDI862.1345 FDA UDI868.1890 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 2 Milliliter FDA UDI
Omnipod Insulin Management System by Insulet Corporation — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10385081120036 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Insulet Corporation
- EUDAMED SRN
- US-MF-000007948
- Authorised Representative
- Insulet Netherlands B.V. NL-AR-000002337
Sources (2)
- EUDAMED 3f481e46-a537-4f3a-a07b-1ae7d1a1a4fb 61 fields · synced Jul 31, 2026
- FDA UDI d9894619-6b84-4124-9962-5f013833da1a 36 fields · synced May 30, 2026