FDA.reportPublic FDA data

Kurin Blood Culture Collection Set

Primary DI
00857606008318
Brand
Kurin Blood Culture Collection Set
Company
Kurin, Inc.
Model
TJ-123
Device description
"Needle Gauge/Type = 23/Standard, Lock Type = Non-Vented, Set Length = 12"", Blood Collection Holder = Short Saf-T Adapter"
Published
2023-07-21
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
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162233000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162233000Kurin Blood Culture Collection SetPathway, LLC2016-12-23JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857606008318PrimaryGS10
20857606008312Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857606008318008576060083188576060083180857606008318
2085760600831220857606008312

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, invasiveA collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.

Regulatory Flags#

DUNS number
036018378
Device count
200
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857606008103Kurin Blood Culture Collection SetSJ-PIV102023-07-21
00857606008226Kurin Blood Culture Collection SetSJ-PIV42023-07-21
00857606008233Kurin Blood Culture Collection SetDJ-PIV182023-07-21
00857606008240Kurin Blood Culture Collection SetMJ-PIV182023-07-21
00857606008257Kurin Blood Culture Collection SetTJ-PIV182023-07-21
00857606008264Kurin Blood Culture Collection SetDJ-1212023-07-21
00857606008271Kurin Blood Culture Collection SetTJ-1212023-07-21
00857606008288Kurin Blood Culture Collection SetTJ-PIV122023-07-21
00857606008295Kurin Blood Culture Collection SetTJ-2232023-07-21
00857606008301Kurin Blood Culture Collection SetTJ-2212023-07-21
00857606008325Kurin Blood Culture Collection SetMJ-PIV122023-07-21
00857606008332Kurin Blood Culture Collection SetMJ-2232023-07-21
00857606008349Kurin Blood Culture Collection SetMJ-2212023-07-21
00857606008363Kurin Blood Culture Collection SetMJ-2212023-07-21
00857606008370Kurin Blood Culture Collection SetDJ-PIV122023-07-21
00857606008387Kurin Blood Culture Collection SetDJ-2232023-07-21
00857606008394Kurin Blood Culture Collection SetDJ-2212023-07-21
00857606008400Kurin Blood Culture Collection SetDJ-1232023-07-21
00857606008417Kurin Blood Culture Collection SetMJ-1232023-07-21
20857606008107Kurin Blood Culture Collection SetSJ-PIV102023-07-21

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