DRAGON HEART MEDICAL, INC.

Address:300 W Lake St,Elmhurst,IL,60126,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) (10)

Premarket Exempt

Clear

Summit International - B346MC8004T0 Catalog Number : MC8004T

Device Description : Quad-port extension set

Device Class : 2

Duns Number: 841522985

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Summit International - B346MES3601 Catalog Number : SMES360

Device Description : 360" Coiled extension set

Device Class : 2

Duns Number: 841522985

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Summit International - B346MSCE120101 Catalog Number : MSCE-120.1.0

Device Description : 120" COILED EXT SET, ID1.0xOD2.0MM

Device Class : 2

Duns Number: 841522985

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Summit International - B346MSCE120151 Catalog Number : MSCE-120.1.5

Device Description : 120" COILED EXT SET, ID1.5xOD2.5MM

Device Class : 2

Duns Number: 841522985

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Summit International - B346MSCE160101 Catalog Number : MSCE-160.1.0

Device Description : 160" COILED EXT SET, ID1.0xOD2.0MM

Device Class : 2

Duns Number: 841522985

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Summit Medical - B346R0011 Catalog Number : 10

Device Description : NRHZ: A sterile device designed to be securely attached to the septum end of a v NRHZ: A sterile device designed to be securely attached to the septum end of a vial to create a channel, by spiking through the vial's sealed stopper, to allow access to the contents of the vial. This device is intended to reduce risk of unwanted exposure to the vial's contents (e.g., liquid medication) by providing a sterile pathway between the vial and a recipient receptacle/device for subsequent delivery to a patient. It typically consists of polyvinyl chloride (PVC) screw cap with an internal spike and an external connector. This is a single-use device.

Device Class :

Duns Number: 841522985

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

Summit International - B346R0021 Catalog Number : R002

Device Description : Product consist of piercing spike and cover, the twist off-connector and an inte Product consist of piercing spike and cover, the twist off-connector and an integrated vial adaptor for access to drugs/solution vials. Indicated to serve as a connecting port between IV bag and external IV line.

Device Class : 2

Duns Number: 841522985

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Summit International - B346SMCE160151 Catalog Number : SMCE-160.1.5

Device Description : 160" Coiled extension set

Device Class : 2

Duns Number: 841522985

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Summit International - B346SMCE40101 Catalog Number : SMCE-40.1.0

Device Description : 40" COILED EXT SET, ID1.0xOD2.0MM

Device Class : 2

Duns Number: 841522985

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Summit International - B346SMCE40151 Catalog Number : SMCE-40.1.5

Device Description : 40" COILED EXT SET, ID1.5xOD2.5MM

Device Class : 2

Duns Number: 841522985

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

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