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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, non-software-dosing FDA UDI
Device Name
DANA Diabecare 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
1 FDA UDI
Description
DANA Diabecare 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
08809220584855 FDA UDI
510(k) Number
K063126 FDA UDI
FDA Product Code
LZG FDA UDI
GMDN Term
Ambulatory insulin infusion pump, electronic, non-software-dosing 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

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ambulatory insulin infusion pump, electronic, non-software-dosing

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, non-software-dosing.

Cleared under the same submission

K063126 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sooil Development Co., Ltd

Sources (1)

  • FDA UDI 97f0d64d-25c6-4b92-ab88-c07161ddaa32 34 fields · synced May 30, 2026