MARKETLAB INC.

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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

Needle, hypodermic, single lumen (FMI) (3) Syringe, piston (FMF) (3) Catheter, intravascular, therapeutic, short-term less than 30 days (FOZ) (1) Container, sharps (MMK) (1) TUBE, COLLECTION, CAPILLARY BLOOD (GIO) (1) Tubes, vials, systems, serum separators, blood collection (JKA) (1)

Premarket Exempt

No Yes

Clear

Marketlab Inc - 00817517020731 Catalog Number : 7135

Device Description : IB Filter Sampler Blood Serum

Device Class : 2

Duns Number: 848917027

Premarket Exempt : No

Product Code : JKA

Prescription Use : No

Device Count : 1

Marketlab Inc - 00817517020748 Catalog Number : 7679

Device Description : Serum Bilirubin Capillary Collection 200ul 50/pk

Device Class :

Duns Number: 848917027

Premarket Exempt : No

Product Code : GIO

Prescription Use : No

Device Count : 50

Marketlab Inc - 00817517020755 Catalog Number : KML0384

Device Description : 8qt. Sharps Container Mailbox Lid-Each

Device Class : 2

Duns Number: 848917027

Premarket Exempt : No

Product Code : MMK

Prescription Use : No

Device Count : 1

Marketlab Inc - 00817517020762 Catalog Number : 42468

Device Description : 30cc/24Fr 100% Silicone Foley Catheter PK12

Device Class :

Duns Number: 848917027

Premarket Exempt : No

Product Code : FOZ

Prescription Use : No

Device Count : 12

Marketlab Inc - 00817517020779 Catalog Number : 43565

Device Description : 21-Gauge Shot Prep Kit

Device Class :

Duns Number: 848917027

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

Marketlab Inc - 00817517020793 Catalog Number : 43567

Device Description : 22-Gauge Shot Prep Kit

Device Class :

Duns Number: 848917027

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

Marketlab Inc - 00817517020816 Catalog Number : 43569

Device Description : 23-Gauge Shot Prep Kit

Device Class :

Duns Number: 848917027

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

Marketlab Inc - 00817517020830 Catalog Number : 43573

Device Description : 18-Gauge Blood Draw Kit

Device Class :

Duns Number: 848917027

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

Marketlab Inc - 00817517020854 Catalog Number : 43575

Device Description : 20-Gauge Blood Draw Kit

Device Class :

Duns Number: 848917027

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

Marketlab Inc - 00817517020878 Catalog Number : 43577

Device Description : 21-Gauge Blood Draw Kit

Device Class : 2

Duns Number: 848917027

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

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