FDA.reportPublic FDA data

Summit Medical

Primary DI
B346R0011
Brand
Summit Medical
Company
DRAGON HEART MEDICAL, INC.
Model
R001
Catalog number
10
Device description
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.
Published
2018-09-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B346R00129PackageHIBCC50In Commercial Distribution
B346R0011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical air terminal unitA device that is a component of a medical gas pipeline system or a medical gas/vacuum pipeline system that has a gas-specific outlet connection for medical air. It is designed to be mounted to wall-mounted medical supply units, utility supply systems (ceiling pendants), or directly to a wall, and functions as the outlet assembly of a gas pipeline system to which the operator can connect and disconnect a device, typically anaesthesia systems, ventilators, respiratory devices and devices that are powered using this gas type. On disconnection of the medical device from the outlet, it will self seal the gas pipeline system preventing gas leakage to the environment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
841522985
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B346SMCE2640Summit International SMCE264SMCE2642026-05-04
B346MES3601Summit International SMES360SMES3602021-05-04
B346MC8004T0Summit International MC8004TMC8004T2021-05-03
B346MSCE120101Summit International MSCE-120.1.0MSCE-120.1.02021-05-03
B346MSCE120151Summit International MSCE-120.1.5MSCE-120.1.52021-05-03
B346MSCE160101Summit International MSCE-160.1.0MSCE-160.1.02021-05-03
B346R0021Summit International R002R0022021-05-03
B346SMCE160151Summit International SMCE-160.1.5SMCE-160.1.52021-05-03
B346SMCE40101Summit International SMCE-40.1.0SMCE-40.1.02021-05-03
B346SMCE40151Summit International SMCE-40.1.5SMCE-40.1.52021-05-03
B346SMCE60101Summit International SMCE-60.1.0SMCE-60.1.02021-05-03
B346SMCE60151Summit International SMCE-60.1.5SMCE-60.1.52021-05-03
B346SMCE80101Summit International SMCE-80.1.0SMCE-80.1.02021-05-03
B346SMCE80151Summit International SMCE-80.1.5SMCE-80.1.52021-05-03
B346SME360LV1Summit International SME360LVSME360LV2021-05-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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05051684018527LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018534LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018541LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018558LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018565LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018572LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018589LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018596LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018602LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018619LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018626LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018633LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018640LifeguardAngiodynamics, Inc.FPA2026-06-23
00811505030573IvenixFresenius Kabi AGFPA2026-06-02
00382905168031BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
00382905168000BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
00085412676630DUO-VENTBAXTER HEALTHCARE CORPORATIONFPA2023-07-11
00634624911109Precision Delivery Bifurcated IV Extension SetQUEST MEDICAL INCFPA2022-12-19
00634624911048High-Flow Extension SetQUEST MEDICAL INCFPA2022-12-12
00634624101159Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624101258Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624101302Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06