D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES
DRAGON HEART MEDICAL, INC.
DRAGON HEART MEDICAL, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004735647 | 3004735647 | DRAGON HEART MEDICAL, INC. | 1 | Y | 2026-01-01 | 11101 Franklin Ave Ste 100 Franklin Park IL US 60131 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 63919 | 2016509127 | K101368 | D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES | FPA | 2010-11-18 |
| 63919 | 2070305998 | K043235 | DRAGON HEART I.V. SET | FPA | 2005-03-08 |
| 63919 | 1088820562 | ||||
| 63919 | 1841308009 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FPA | 2 | 2010-11-18 |
PMN#
GUDID#
Summit International - "264"" COILED MRI EXT SET. Fixed Male/Female Luers. Standard Pinch Clamp"
2026-05-04
Summit International - "360"" Coiled extension set"
2021-05-04
Summit International - Quad-port extension set
2021-05-03
Summit International - "120"" COILED EXT SET, ID1.0xOD2.0MM"
2021-05-03
Summit International - "120"" COILED EXT SET, ID1.5xOD2.5MM"
2021-05-03
Summit International - "160"" COILED EXT SET, ID1.0xOD2.0MM"
2021-05-03
Summit International - 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.
2021-05-03
Summit International - "160"" Coiled extension set"
2021-05-03
Summit International - "40"" COILED EXT SET, ID1.0xOD2.0MM"
2021-05-03
Summit International - "40"" COILED EXT SET, ID1.5xOD2.5MM"
2021-05-03
Summit International - "60"" COILED EXT SET, ID1.0xOD2.0MM"
2021-05-03
Summit International - "60"" COILED EXT SET, ID1.5xOD2.5MM"
2021-05-03
Summit International - "80"" COILED EXT SET, ID1.0xOD2.0MM"
2021-05-03
Summit International - "80"" COILED EXT SET, ID1.5xOD2.5MM"
2021-05-03
Summit International - "360"" Coiled MRI extension set, low volume. "
2021-05-03
Summit Medical - 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.
2018-09-03