Q-CORE MEDICAL LTD

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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

Accessories, Pump, Infusion (MRZ) (6) Pump, Infusion (FRN) (4)

Premarket Exempt

Clear

Mini Cradle with Splitter- US - 17290109150113 Catalog Number : 17000-026-0007

Device Class : 2

Duns Number: 533108028

Premarket Exempt : No

Product Code : MRZ

Prescription Use : Yes

Device Count : 1

Sapphire M.T. with Bolus and Splitter Kit -US - 17290109150120 Catalog Number : 17000-028-0062

Device Class : 2

Duns Number: 533108028

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Sapphire Epidural Infusion Kit-US - 17290109150137 Catalog Number : 17000-031-0027

Device Class : 2

Duns Number: 533108028

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

SapphirePlus Infusion Kit - US - 17290109150151 Catalog Number : 17000-033-0001

Device Class : 2

Duns Number: 533108028

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Multi-Pump Mounting System kit single pack for US - 17290109150175 Catalog Number : 17000-020-0008

Device Class : 2

Duns Number: 533108028

Premarket Exempt : No

Product Code : MRZ

Prescription Use : No

Device Count : 1

Sapphire Power Supply (fixed head) - 17290109150182 Catalog Number : 15072-000-0007-ASM

Device Description : Sapphire Power Supply, USA type with metal ODU connector

Device Class : 2

Duns Number: 533108028

Premarket Exempt : No

Product Code : MRZ

Prescription Use : Yes

Device Count : 1

Bolus - US - 17290109150199 Catalog Number : 15071-000-0005

Device Class : 2

Duns Number: 533108028

Premarket Exempt : No

Product Code : MRZ

Prescription Use : Yes

Device Count : 1

Integrated Power Supply US - 17290109150205 Catalog Number : 15072-000-0010

Device Class : 2

Duns Number: 533108028

Premarket Exempt : No

Product Code : MRZ

Prescription Use : Yes

Device Count : 1

SapphirePlus Infusion Kit - US - 17290109150229 Catalog Number : 17000-033-0001

Device Class : 2

Duns Number: 533108028

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Splitter- US - 17290109150274 Catalog Number : 15043-000-0005

Device Class :

Duns Number: 533108028

Premarket Exempt : No

Product Code : MRZ

Prescription Use : Yes

Device Count : 1

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