FDA.reportPublic FDA data

YI XIN Sterile Syringe For Single Use

Primary DI
06945060501057
Brand
YI XIN Sterile Syringe For Single Use
Company
Jiang Xi Sanxin Medtec Co., Ltd.
Model
Two-piece 10mL
Device description
YI XIN Sterile Syringe For Single Use, without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from the body.
Published
2019-09-26
Public version status
Update
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
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050999000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050999000YI XIN STERILE SYRINGE FOR SINGLE USEJiangxi Sanxin (Eversincere) Medical Devices Group2005-09-02FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16945060501054PackageGS1100In Commercial Distribution
26945060501051PackageGS112In Commercial Distribution
06945060501057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694506050105416945060501054
2694506050105126945060501051
06945060501057069450605010576945060501057

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. 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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