FDA.reportPublic FDA data

Summit International

Primary DI
B346MSCE120101
Brand
Summit International
Company
DRAGON HEART MEDICAL, INC.
Model
MSCE-120.1.0
Catalog number
MSCE-120.1.0
Device description
"120"" COILED EXT SET, ID1.0xOD2.0MM"
Published
2021-05-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
B346MSCE120101PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
841522985
Device count
1
DM exempt
true
Lot or batch
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
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
B346R0011Summit MedicalR001102018-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10813153027339CodanCodan US CorporationFPA2026-07-31
10813153028312CodanCodan US CorporationFPA2026-07-31
10850048235196HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
10850048235264HMG IV Administration SetHartman Medical Group LLCFPA2026-07-31
20850048235193HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
00382903935314NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
10813153028329CodanCodan US CorporationFPA2026-07-17
00827989008243MedSafetyHealth Care Logistics, Inc.FPA2026-07-10
05051684018473LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018480LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018497LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018503LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018510LifeportAngiodynamics, Inc.FPA2026-06-23
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