Identity
- Trade Name
- Omnipod FDA UDI
- Generic Name
- Ambulatory insulin infusion pump/blood glucose analyser system FDA UDI
- Device Name
- Eros Pod Insulin pump. FDA UDI
- Model / Reference
- ZXP420 FDA UDI
- Description
- Eros Pod Insulin pump. FDA UDI
Identifiers
- Catalog Number
- 14000 FDA UDI
- Primary DI / UDI-DI
- 10385081120005 FDA UDI
- FDA Product Code
- LZG FDA UDINBW FDA UDINDC FDA UDI
- GMDN Term
- Ambulatory insulin infusion pump/blood glucose analyser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 FDA UDI862.1345 FDA UDI868.1890 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
Dimensions & Sizes
- Size
- Total Volume — 2 Milliliter FDA UDI
Category: Ambulatory insulin infusion pump/blood glucose analyser system
Omnipod by Insulet Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ambulatory insulin infusion pump/blood glucose analyser system.
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- t:slim X2 Insulin Pump with Control-IQ — Tandem Diabetes Care, Inc. · Class II
- t:slim X2 Insulin Pump with Control-IQ — Tandem Diabetes Care, Inc. · Class II
- t:slim X2 Insulin Pump with Basal-IQ — Tandem Diabetes Care, Inc. · Class III
- t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM — Tandem Diabetes Care, Inc. · Class III
- t:slim X2 Insulin Pump with Basal-IQ — Tandem Diabetes Care, Inc. · Class II
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 71af660f-a114-4d32-8746-279ef498d3e3 36 fields · synced Jun 9, 2026