FDA.reportPublic FDA data

Kurin Blood Culture Collection Set

Primary DI
20857606008299
Brand
Kurin Blood Culture Collection Set
Company
Kurin, Inc.
Model
TJ-223
Device description
Needle Gauge/Type = 23/Push Button, 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
Rx
false
OTC
false
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
00857606008295PrimaryGS10
20857606008299Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857606008295008576060082958576060082950857606008295
2085760600829920857606008299

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
036018378
Device count
200
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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