Merit Pharmaceutical

Merit Pharmaceutical

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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

Set, Administration, Intravascular (FPA) (3) Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days (FOZ) (2) Syringe, Piston (FMF) (2) Container, I.V. (KPE) (1) Infusor, Pressure, For I.V. Bags (KZD) (1) Needle, Hypodermic, Single Lumen (FMI) (1)

Premarket Exempt

No Yes

Clear

MeritPoint - 00853620005173 Catalog Number :

Device Class : 2

Duns Number: 093370369

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

IV Catheter - 00853620005180 Catalog Number :

Device Class :

Duns Number: 093370369

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

Empty IV Bag 500mL - 00853620005197 Catalog Number :

Device Class : 2

Duns Number: 093370369

Premarket Exempt : No

Product Code : KPE

Prescription Use : Yes

Device Count : 1

IV Set With In-Line Filter - 00853620005203 Catalog Number :

Device Class : 2

Duns Number: 093370369

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

IV Set - 00853620005210 Catalog Number :

Device Class : 2

Duns Number: 093370369

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

IV Catheter - 00853620005227 Catalog Number :

Device Class : 2

Duns Number: 093370369

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

3cc Syringe - 00853620005234 Catalog Number :

Device Class : 2

Duns Number: 093370369

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

100cc Syringe - 00853620005241 Catalog Number :

Device Class : 2

Duns Number: 093370369

Premarket Exempt : No

Product Code : FMF

Prescription Use : No

Device Count : 1

IV Administration Set - 00853620005272 Catalog Number :

Device Class : 2

Duns Number: 093370369

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Pressure Infuser - 00853620005289 Catalog Number :

Device Class : 1

Duns Number: 093370369

Premarket Exempt : Yes

Product Code : KZD

Prescription Use : Yes

Device Count : 1

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