FDA.reportPublic FDA data

Coeur Acist

Primary DI
M297632080
Brand
Coeur Acist
Company
COEUR, INC.
Model
C465-3208
Catalog number
C465-3208
Device description
20” TRANSFER SET WITH SWABABLE VALVE AND SHORT SPIKE
Published
2016-07-14
Public version status
Update
Distribution status
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
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
M297632085PackageHIBCC50In Commercial Distribution
M297632086PackageHIBCC100In Commercial Distribution
M297632080PrimaryHIBCC0

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
Length20Inch

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.

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

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Primary DI, Brand, Company table
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