FDA.reportPublic FDA data

INT

Primary DI
06950900921704
Brand
INT
Company
Shanghai Kindly Medical Instruments Co., Ltd.
Model
YCK111
Device description
Screw type Y connector,torque device(plastic core), insertion tool;
Published
2023-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170024000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170024000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16950900921701PackageGS125In Commercial Distribution
26950900921708PackageGS150In Commercial Distribution
46950900921702PackageGS1200In Commercial Distribution
56950900921709PackageGS1100In Commercial Distribution
06950900921704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695090092170116950900921701
2695090092170826950900921708
4695090092170246950900921702
5695090092170956950900921709
06950900921704069509009217046950900921704

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guidewire introduction sleeveA noninvasive tubular device designed to be connected to the proximal (external) end of an in situ vascular introducer or guide catheter, and inserted beyond the pre-opened haemostatic valve, to facilitate introduction of a vascular guidewire. It is intended to channel the guidewire to prevent bending/kinking as forward pressure is applied. This is a single-use device.

Regulatory Flags#

DUNS number
420827639
Device count
1
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
06950900900693INT,SlideCathACJL605F11252023-09-11
06950900900709INT,SlideCathACJL606F11252023-09-11
06950900900716INT,SlideCathACJR304F11002023-09-11
06950900900723INT,SlideCathACJR307F11002023-09-11
06950900900730INT,SlideCathACJR355F11252023-09-11
06950900900747INT,SlideCathACJR356F11252023-09-11
06950900900754INT,SlideCathACJR405F11252023-09-11
06950900900761INT,SlideCathACJR406F11252023-09-11
06950900900778INT,SlideCathACJR455F11002023-09-11
06950900900785INT,SlideCathACJR456F11002023-09-11
06950900900792INT,SlideCathACJR456F11252023-09-11
06950900900808INT,SlideCathACJR457F11002023-09-11
06950900900815INT,SlideCathACJR505F11252023-09-11
06950900900822INT,SlideCathACJR506F11252023-09-11
06950900900839INT,SlideCathACJR605F11252023-09-11
06950900900846INT,SlideCathACJR606F11252023-09-11
06950900900853INT,SlideCathACTIG24F11002023-09-11
06950900900860INT,SlideCathACTIG25F11002023-09-11
06950900900877INT,SlideCathACTIG27F11002023-09-11
06950900900884INT,SlideCathACTIG34F11002023-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10193489064490NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489064513NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
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