FDA.reportPublic FDA data

"Kuring 23 Gauge, Push Button Need w/12"" Tubing, BD Vacutainer"

Primary DI
00857606008035
Brand
"Kuring 23 Gauge, Push Button Need w/12"" Tubing, BD Vacutainer"
Company
Kurin, Inc.
Model
D-21223/DJ-223
Published
2018-09-28
Public version status
Update
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
10857606008018PackageGS150Not in Commercial Distribution
10857606008032PackageGS150In Commercial Distribution
00857606008035PrimaryGS10
20857606008039Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085760600801810857606008018
1085760600803210857606008032
00857606008035008576060080358576060080350857606008035
2085760600803920857606008039

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, invasiveA collection of sterile 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 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.

Sterilization Methods#

Method table
Method

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
00857606008318Kurin Blood Culture Collection SetTJ-1232023-07-21
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

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08887629000053BUCANSP TECH PTE LTDJKA2026-05-29
08887629000060BTANSP TECH PTE LTDJKA2026-05-29
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044793CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
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08586015044823CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044878CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
10197344019649MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-04-23
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