Identity
- Trade Name
- Omnipod 5 Pod FDA UDI
- Generic Name
- Ambulatory insulin infusion pump/interstitial glucose monitoring system FDA UDI
- Device Name
- Omnipod 5 Pod FDA UDI
- Model / Reference
- POD-BLE-H1-520 FDA UDI
- Description
- Omnipod 5 Pod FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10385083000114 FDA UDI
- FDA Product Code
- QFG FDA UDIQJI FDA UDI
- GMDN Term
- Ambulatory insulin infusion pump/interstitial glucose monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5730 FDA UDI862.1356 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Pod by Insulet Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Insulet Corporation
Sources (1)
- FDA UDI 83f9e052-d144-4469-8ea5-c1bc6b9937e5 35 fields · synced Jun 9, 2026