SOOIL DEVELOPMENT CO.,LTD

Address:62, Yonggu-daero 2325beon-gil, Giheung-gu,Yongin-si Gyeonggi,KR

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Warmer, Thermal, Infusion Fluid (LGZ) (5) Accessories, Pump, Infusion (MRZ) (2) Pump, Infusion, Insulin (LZG) (2)

Premarket Exempt

Clear

Soft-Release-ST - 08809220580413 Catalog Number :

Device Description : Soft-Release-ST is an infusion set to connect to SOOIL's insulin reservoir for u Soft-Release-ST is an infusion set to connect to SOOIL's insulin reservoir for using insulin pump. It is inserted in the subcutaneous tissue and Not intended for use into blood vessel.

Device Class :

Duns Number: 688006266

Premarket Exempt : No

Product Code : LZG

Prescription Use : Yes

Device Count : 1

DANA 3cc Syringe - 08809220580765 Catalog Number :

Device Description : DANA 3cc Syringe is an insulin reservoir for using insulin pump. It is installed DANA 3cc Syringe is an insulin reservoir for using insulin pump. It is installed into the SOOIL's insulin pump and connected to an infusion set in order to deliver insulin to the patients.

Device Class :

Duns Number: 688006266

Premarket Exempt : No

Product Code : MRZ

Prescription Use : Yes

Device Count : 1

DANA Diabecare - 08809220580789 Catalog Number :

Device Description : DANA Diabecare ⅡS is external programmable syringe infusion pump used for the su 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.

Device Class : 2

Duns Number: 688006266

Premarket Exempt : No

Product Code : LZG

Prescription Use : Yes

Device Count : 1

2 Syringe Caps and 2 Battery Caps - 08809220580994 Catalog Number :

Device Description : Syringe cap and battery cap are accessories for insulin pump use. They helps the Syringe cap and battery cap are accessories for insulin pump use. They helps the insulin pump used properly.

Device Class : 2

Duns Number: 688006266

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

2 Linking Screws - 08809220581007 Catalog Number :

Device Description : The linking screw is an accessory for insulin pump use. The role is to change th The linking screw is an accessory for insulin pump use. The role is to change the rotary motion of the motor in insulin pump to rectilinear motion of plunger in insulin syringe reservoir.

Device Class : 2

Duns Number: 688006266

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

3.6V Battery - 08809220581014 Catalog Number :

Device Description : Description: The battery is an accessory for insulin pump use. it is the main po Description: The battery is an accessory for insulin pump use. it is the main power of DANA insulin pump.

Device Class :

Duns Number: 688006266

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

DANA Diabecare - 08809220581045 Catalog Number :

Device Class : 2

Duns Number: 688006266

Premarket Exempt : No

Product Code : MRZ, LGZ

Prescription Use : Yes

Device Count : 1

DANA Easy Setter - 08809220581052 Catalog Number :

Device Description : DANA Easy Setter is an accessory for insulin pump use. it helps the length of li 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.

Device Class : 2

Duns Number: 688006266

Premarket Exempt : No

Product Code : LGZ

Prescription Use : No

Device Count : 1

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