Identity
- Trade Name
- 3.6V Battery FDA UDI
- Generic Name
- Ambulatory insulin infusion pump, electronic FDA UDI
- Device Name
- Description: The battery is an accessory for insulin pump use. it is the main power of DANA insulin pump. FDA UDI
- Model / Reference
- Bobbin FDA UDI
- Description
- Description: The battery is an accessory for insulin pump use. it is the main power of DANA insulin pump. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809220581014 FDA UDI
- 510(k) Number
- K063126 FDA UDI
- FDA Product Code
- LGZ FDA UDI
- GMDN Term
- Ambulatory insulin infusion pump, electronic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ambulatory insulin infusion pump, electronic
3.6V Battery by Sooil Development Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ambulatory insulin infusion pump, electronic.
- Omnipod — Insulet Corporation · Class II
- PARADIGM® REAL-time — MEDTRONIC MINIMED, INC. · Class III
- Omnipod DASH Pod — Insulet Corporation · Class II
- Omnipod — Insulet Corporation · Class II
- PARADIGM® REAL-time — MEDTRONIC MINIMED, INC. · Class III
- PARADIGM® REAL-time — MEDTRONIC MINIMED, INC. · Class III
- PARADIGM® REAL-time — MEDTRONIC MINIMED, INC. · Class III
- PARADIGM® REAL-time — MEDTRONIC MINIMED, INC. · Class III
Cleared under the same submission
K063126 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sooil Development Co., Ltd
Sources (1)
- FDA UDI 7079739f-0f6c-44ed-b857-f9d7bc484ec1 34 fields · synced May 30, 2026