FDA.reportPublic FDA data

Coeur

Primary DI
M297130410
Brand
Coeur
Company
COEUR, INC.
Model
C405-3041
Catalog number
C405-3041
Device description
7 in. Transfer set with Long Spike
Published
2016-07-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPKTubing, Fluid Delivery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPKTubing, Fluid DeliveryGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063114000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063114000DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVESCoeur, Inc.2007-02-09FPK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M297130415PackageHIBCC50In Commercial Distribution
M297130416PackageHIBCC2In Commercial Distribution
M297130410PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiographic procedure tubingA flexible, cylindrical device that typically connects a contrast imaging syringe to a patient cannula for the conduction of contrast media and flushing fluids to a patient during diagnostic radiographic procedures [e.g., angiography or computed tomography (CT)]. The device is made of synthetic polymers, will accommodate low and high pressures, and is provided in various lengths with quick connecting fittings (e.g., Luer-lock).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep product in clean, dry location. Avoid direct rays, heat and high humidity, and ultraviolet rays such as a germicidal light.

Contacts#

Phone, Email table
PhoneEmail
1-800-296-5893customer.service@coeurinc.com

Regulatory Flags#

DUNS number
132515441
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M297722010CoeurC853-2201C853-22012019-02-11
M297722070CoeurC853-2207C853-22072019-02-11
M297731020CoeurC853-3102C853-31022019-02-11
M297732010CoeurC853-3201C853-32012019-02-11
M297732020CoeurC853-3202C853-32022019-02-11
M297100600CoeurC405-0060C405-00602016-07-14
M297100610CoeurC405-0061C405-00612016-07-14
M297101230CoeurC405-0123C405-01232016-07-14
M297102010CoeurC405-0201C405-02012016-07-14
M297102030CoeurC405-0203C405-02032016-07-14
M297115010CoeurC405-1501C405-15012016-07-14
M297115080CoeurC405-1508C405-15082016-07-14
M297115490CoeurC405-1549C405-15492016-07-14
M297115590CoeurC405-1559C405-15592016-07-14
M297115690CoeurC405-1569C405-15692016-07-14
M297118010CoeurC405-1801C405-18012016-07-14
M297118020CoeurC405-1802C405-18022016-07-14
M297120410CoeurC405-2041C405-20412016-07-14
M297120420CoeurC405-2042C405-20422016-07-14
M297121550CoeurC405-2155C405-21552016-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450628307Merit Medical®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.FPK2024-12-07
10192253003338MonojectCardinal Health 200, LLCFPK2024-08-21
10192253003345MonojectCardinal Health 200, LLCFPK2024-08-21
10192253003352MonojectCardinal Health 200, LLCFPK2024-08-21
00616258024554Swabbable Valve Transfer SetBayer Medical Care Inc.FPK2024-05-06
00616258024561MEDRAD® Twist & Go Disposable Syringe 150mL with Quick Fill TubeBayer Medical Care Inc.FPK2024-05-06
00616258024820MEDRAD® Twist & Go Disposable Syringe 150mL with Quick Fill TubeBayer Medical Care Inc.FPK2024-05-06
10884450325312Merit Medical®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.FPK2021-04-05
00849884005141VYGONVygon CorporationFPK2021-01-28
10849884002260VYGONVygon CorporationFPK2020-06-02
00849884002720VYGONVygon CorporationFPK2020-06-01
0063462495724425ft/7.6m IV Extension Set QUEST MEDICAL INCFPK2020-04-13
10849884002666VYGONVygon CorporationFPK2020-04-02
10849884002765VYGONVygon CorporationFPK2020-04-02
10849884002581VYGONVygon CorporationFPK2020-04-01
00849884004441VYGONVygon CorporationFPK2020-03-12
00849884003956VYGONVygon CorporationFPK2020-01-28
00849884004007VYGONVygon CorporationFPK2020-01-28
10351688507112MedexICU MEDICAL, INC.FPK2020-01-13
00849884000320VYGONVygon CorporationFPK2019-12-16
00849884000559VYGONVygon CorporationFPK2019-12-16
00849884000566VYGONVygon CorporationFPK2019-12-16
00634624957817Exoflex 10.5in. IVExtension Set QUEST MEDICAL INCFPK2019-12-09
00849884000269VYGONVygon CorporationFPK2019-11-14
00849884000313VYGONVygon CorporationFPK2019-11-14
00849884000375VYGONVygon CorporationFPK2019-11-14
00849884000443VYGONVygon CorporationFPK2019-11-14
00849884000450VYGONVygon CorporationFPK2019-11-14
00849884000467VYGONVygon CorporationFPK2019-11-14
00849884000535VYGONVygon CorporationFPK2019-11-14