EMED TECHNOLOGIES CORPORATION

Address:1262 Hawks Flight Ct Ste 200,EL DORADO HILLS,CA,95762,US

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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) (6) Tubing, Fluid Delivery (FPK) (3) Immunoglobulin G (Igg) Infusion System (PKP) (1)

Premarket Exempt

Clear

AccuFlo - 00817708020229 Catalog Number : FLO-100

Device Description : 92" IV Set w/ IV Flow Regulator

Device Class :

Duns Number: 622637544

Premarket Exempt : No

Product Code : FPK

Prescription Use : Yes

Device Count : 50

AccuFlo - 00817708020243 Catalog Number : FLO-110

Device Description : Fluid Delivery Set

Device Class :

Duns Number: 622637544

Premarket Exempt : No

Product Code : FPK

Prescription Use : Yes

Device Count : 50

AccuFlo - 00817708020267 Catalog Number : FLO-120

Device Description : 92" IV Set w/ IV Flow Regulator with a needle free site

Device Class :

Duns Number: 622637544

Premarket Exempt : No

Product Code : FPK

Prescription Use : Yes

Device Count : 50

SCIg60 Infusion System - 00817708020274 Catalog Number : FP-0010002

Device Description : SCIg60 Infuser (Mechanical Pump) Assembly

Device Class : 2

Duns Number: 622637544

Premarket Exempt : No

Product Code : PKP

Prescription Use : Yes

Device Count : 1

VersaRate - 00817708020304 Catalog Number : FP-0010003

Device Description : Variable Infusion Flow Rate Controller set

Device Class :

Duns Number: 622637544

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 25

Infuset - 00817708020328 Catalog Number : FP-0010004

Device Description : Infuset-1850, Flow Control Infusion set

Device Class :

Duns Number: 622637544

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 25

Infuset - 00817708020342 Catalog Number : FP-0010005

Device Description : Infuset-930, Flow Control Infusion set

Device Class :

Duns Number: 622637544

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 25

Infuset - 00817708020366 Catalog Number : FP-0010006

Device Description : Infuset-820, Flow Control Infusion set

Device Class :

Duns Number: 622637544

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 25

Infuset - 00817708020380 Catalog Number : FP-0010007

Device Description : Infuset-290, Flow Control Infusion set

Device Class :

Duns Number: 622637544

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 25

Infuset - 00817708020403 Catalog Number : FP-0010008

Device Description : Infuset-190, Flow Control Infusion set

Device Class :

Duns Number: 622637544

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 25

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