FDA.reportPublic FDA data

EMSRUN

Primary DI
06974567743462
Brand
EMSRUN
Company
Wuxi Emsrun Technology Co., Ltd.
Model
CR-B1
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JCYCatheter, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCYCatheter, InfusionGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974567743462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974567743462069745677434626974567743462

GMDN Terms#

Term, Definition table
TermDefinition
Coronary artery infusion catheterA sterile flexible tube, typically with a double-lumen, designed to access the coronary artery vasculature for local infusion of diagnostic or therapeutic solutions (e.g., angiographic contrast medium, heparin solution, saline), and often to function as a passage for a guidewire to assist its placement in the coronary artery. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
542972552
Device count
1
Premarket 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
06974567745800EMSRUNPZQJ00022023-05-29
06974567741116EMSRUNPZJE00022022-12-02
06974567741147EMSRUNPZSI00082022-12-02
06974567742632EMSRUNPZSI00062022-12-02
06974567742649EMSRUNPZQJ00012022-12-02
06974567740515EMSRUNWSX-H2022-12-06
06974567742267EMSRUNCR-032022-12-06
06974567745411Lightning X Products,IncLXCP1002022-12-07
06974567742717EMSRUNPZBA00012022-12-02
06974567742724EMSRUNPZBA00122022-12-02
86974567746698RHINO RESCUEPZJJ00072023-10-10
86974567746926RHINO RESCUEPZJJ00072023-06-12
9697456774669566974567746694PZJJ00072023-10-10
96974567746923RHINO RESCUEPZJJ00072023-06-12
06974567749631Rhino RescuePZJJ00012022-12-08
06974567746692RHINO RESCUEPZJJ00072024-08-08
06974567746920RHINO RESCUEPZJJ00072024-08-08
06974567747989RHINO RESCUEPZJJ00072023-03-14
16974567747986RHINO RESCUEPZJJ00072023-03-14
06974567745428Lightning X Products,IncLXEFB2022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10680651385250HalyardO&M HALYARD, INC.JCY2023-07-31
30680651385254HalyardO&M HALYARD, INC.JCY2023-07-31
00884908175646TRIPLE LUMEN INFUSION CATHETERSMedical Components, Inc.JCY2023-06-17
50884908175641TRIPLE LUMEN INFUSION CATHETERSMedical Components, Inc.JCY2023-06-17
00884908147056N/AN/AMedical Components, Inc.JCY2019-10-02
00884908147063N/AN/AMedical Components, Inc.JCY2019-10-02
00884908147070N/AN/AMedical Components, Inc.JCY2019-10-02
50884908147051N/AN/AMedical Components, Inc.JCY2019-10-02
50884908147068N/AN/AMedical Components, Inc.JCY2019-10-02
50884908147075N/AN/AMedical Components, Inc.JCY2019-10-02
00884908146394INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
00884908146400INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
00884908146417INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
00884908146424INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
00884908146431INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
50884908146399INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
50884908146405INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
50884908146412INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
50884908146429INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
50884908146436INFUSION CATHETERINFUSION CATHETERMedical Components, Inc.JCY2019-07-30
00884908029048N/AN/AMedical Components, Inc.JCY2019-07-02
50884908029043N/AN/AMedical Components, Inc.JCY2019-07-02
00884908097009TRIPLE LUMEN INFUSION CATHETERSTRIPLE LUMEN INFUSION CATHETERSMedical Components, Inc.JCY2017-03-16
50884908097004TRIPLE LUMEN INFUSION CATHETERSTRIPLE LUMEN INFUSION CATHETERSMedical Components, Inc.JCY2017-03-16
04046964189555Blood Spike AdapterB. BRAUN MEDICAL INC.JCY2016-09-23