DANA Diabecare

FDA UDI

Class II (US FDA UDI)

by Sooil Development Co., Ltd

Identity

Trade Name: DANA Diabecare FDA UDI
Generic Name: Ambulatory insulin infusion pump, electronic FDA UDI
Device Name: DANA Diabecare ⅡS is external programmable syringe infusion pump used for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. The pump is not intended for use with blood or blood products. FDA UDI
Model / Reference: ⅡS FDA UDI
Description: DANA Diabecare ⅡS is external programmable syringe infusion pump used for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. The pump is not intended for use with blood or blood products. FDA UDI

Identifiers

Primary DI / UDI-DI: 08809220580789 FDA UDI
510(k) Number: K063126 FDA UDI
FDA Product Code: LZG 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Ambulatory insulin infusion pump, electronic

DANA Diabecare 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 8c80d801-e639-4b4b-9707-4df7a670aeb0 34 fields · synced Jun 1, 2026