EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED

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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

Pump, Infusion, Elastomeric (MEB) (8) Dispenser, Liquid Medication (KYX) (2)

Premarket Exempt

No Yes

Clear

SMARTeZ Pump - 18859299104017 Catalog Number :

Device Description : SMARTeZ Pump C100-2-50h

Device Class : 2

Duns Number: 662213220

Premarket Exempt : No

Product Code : MEB

Prescription Use : No

Device Count : 1

SMARTeZ Pump - 18859299104024 Catalog Number :

Device Description : SMARTeZ Pump C270-2-135h

Device Class : 2

Duns Number: 662213220

Premarket Exempt : No

Product Code : MEB

Prescription Use : No

Device Count : 1

SMARTeZ Pump - 18859299104031 Catalog Number :

Device Description : SMARTeZ Pump C120-4-30h

Device Class : 2

Duns Number: 662213220

Premarket Exempt : No

Product Code : MEB

Prescription Use : No

Device Count : 1

SMARTeZ Pump - 18859299104048 Catalog Number :

Device Description : SMARTeZ Pump C270-5-54h

Device Class : 2

Duns Number: 662213220

Premarket Exempt : No

Product Code : MEB

Prescription Use : No

Device Count : 1

SMARTeZ Pump - 18859299104055 Catalog Number :

Device Description : SMARTeZ Pump C270-10-27h

Device Class : 2

Duns Number: 662213220

Premarket Exempt : No

Product Code : MEB

Prescription Use : No

Device Count : 1

SMARTeZ Fluid Transfer Set - 18859299180028 Catalog Number :

Device Description : SMARTeZ Fluid Transfer Set (Tube Length 30cm)

Device Class : 1

Duns Number: 662213220

Premarket Exempt : Yes

Product Code : KYX

Prescription Use : No

Device Count : 1

SMARTeZ Fluid Transfer Set - 18859299180110 Catalog Number :

Device Description : SMARTeZ Fluid Transfer Set (Extension Tube 30cm)

Device Class : 1

Duns Number: 662213220

Premarket Exempt : Yes

Product Code : KYX

Prescription Use : No

Device Count : 1

SMARTeZ Pump - 28859299101013 Catalog Number :

Device Description : SMARTeZ Pump 100-200-0.5h

Device Class : 2

Duns Number: 662213220

Premarket Exempt : No

Product Code : MEB

Prescription Use : No

Device Count : 1

SMARTeZ Pump - 28859299101020 Catalog Number :

Device Description : SMARTeZ Pump 250-500-0.5h

Device Class : 2

Duns Number: 662213220

Premarket Exempt : No

Product Code : MEB

Prescription Use : No

Device Count : 1

SMARTeZ Pump - 28859299101037 Catalog Number :

Device Description : SMARTeZ Pump 50-50-1h

Device Class : 2

Duns Number: 662213220

Premarket Exempt : No

Product Code : MEB

Prescription Use : No

Device Count : 1

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