DANA Easy Setter

FDA UDI

Class II (US FDA UDI)

by Sooil Development Co., Ltd

Identity

Trade Name: DANA Easy Setter FDA UDI
Generic Name: Ambulatory insulin infusion pump, electronic FDA UDI
Device Name: DANA Easy Setter is an accessory for insulin pump use. it helps the length of linking screw adjusted properly. If the length adjustment of linking screw is fail, the insulin could not be delivered. FDA UDI
Model / Reference: DANA Easy Setter FDA UDI
Description: DANA Easy Setter is an accessory for insulin pump use. it helps the length of linking screw adjusted properly. If the length adjustment of linking screw is fail, the insulin could not be delivered. FDA UDI

Identifiers

Primary DI / UDI-DI: 08809220581052 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Ambulatory insulin infusion pump, electronic

DANA Easy Setter by Sooil Development Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

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Manufacturer

Manufacturer: Sooil Development Co., Ltd

Sources (1)

FDA UDI 6f684e95-3530-472a-a5d9-ce90a422acb2 34 fields · synced Jun 8, 2026