FDA.reportPublic FDA data

I.V. Catheter

Primary DI
06945060530026
Brand
I.V. Catheter
Company
Jiang Xi Sanxin Medtec Co., Ltd.
Model
Y Type-03(8G/30mm)
Device description
The proposed device, l.V, Catheter, is intended to be inserted in to a patient's vascular system for short term use (no more than 72 hours) to withdraw blood samples or administer fluid intravenously.
Published
2025-03-19
Public version status
New
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
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142797000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142797000I.V. CatheterJiangxi Sanxin Medtec Co., Ltd.2015-06-18FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16945060530023PackageGS150In Commercial Distribution
26945060530020PackageGS14In Commercial Distribution
06945060530026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694506053002316945060530023
2694506053002026945060530020
06945060530026069450605300266945060530026

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral intravenous cannulaA short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. This is a single-use device.

Regulatory Flags#

DUNS number
530079367
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
06945060520010Disposable medical face masksType A (ear-loop type),Large size,Sterile 9.5×17.52025-03-19
06945060520027Disposable medical face masksType A (ear-loop type),Large size,Non-sterile 9.5×2025-03-19
06945060520034Disposable medical face masksType B (tie-on type),Large size,Sterile 9.5×17.5 L2025-03-19
06945060520041Disposable medical face masksType B(tie-on type),Large size,Non-sterile 9.5×17.2025-03-19
06945060520058Disposable medical face masksType A (ear-loop type),Medium Size,sterile 9.5×15.2025-03-19
06945060520065Disposable medical face masksType A (ear-loop type), Medium size,Non-sterile 9.2025-03-19
06945060520072Disposable medical face masksType B (tie-on type),Medium size,Sterile 9.5×15.5 2025-03-19
06945060520089Disposable medical face masksType B(tie-on type),Medium size,Non-sterile 9.5×152025-03-19
06945060520096Disposable medical face masksType A (ear-loop type),Small size,Sterile 9.5×14 L2025-03-19
06945060520102Disposable medical face masksType A (ear-loop type),Small size,Non-sterile 9.5×2025-03-19
06945060520119Disposable medical face masksType B(tie-on type),Small size,Sterile 9.5×14 Leve2025-03-19
06945060520126Disposable medical face masksType B (tie-on type),Small size,Non-sterile 9.5×142025-03-19
06945060520133Disposable medical face masksType A (ear-loop type),size I,Sterile 9.5×14.5 Lev2025-03-19
06945060520140Disposable medical face masksType A (ear-loop type),size I,Non-sterile 9.5×14.52025-03-19
06945060520157Disposable medical face masksType B (tie-on type),size I,Sterile 9.5×14.5 Level2025-03-19
06945060520164Disposable medical face masksType B (tie-on type),size I,Non-sterile 9.5×14.5 L2025-03-19
06945060520171Disposable medical face masksType A (ear-loop type),size II,Sterile 9.5×16 Leve2025-03-19
06945060520188Disposable medical face masksType A (ear-loop type),size II,Non-sterile 9.5×16 2025-03-19
06945060520195Disposable medical face masksType B (tie-on type),size II,Sterile 9.5×16 Level 2025-03-19
06945060520201Disposable medical face masksType B (tie-on type),size II,Non-sterile 9.5×16 Le2025-03-19

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Primary DI, Brand, Company table
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