FDA.reportPublic FDA data

YI XIN Sterile Syringe For Single Use

Primary DI
16945060500156
Brand
YI XIN Sterile Syringe For Single Use
Company
Jiang Xi Sanxin Medtec Co., Ltd.
Model
Three-piece 50mL
Device description
YI XIN Sterile Syringe For Single Use, with needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from the body.
Published
2019-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
16945060500156PackageGS120In Commercial Distribution
26945060500153PackageGS112In Commercial Distribution
06945060500159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694506050015616945060500156
2694506050015326945060500153
06945060500159069450605001596945060500159

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe/needleA 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 non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
530079367
Device count
1
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
true
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
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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