FDA.reportPublic FDA data

Sterile Single-use Syringe with Needle

Primary DI
06920756728499
Brand
Sterile Single-use Syringe with Needle
Company
Jiangxi Hongda Medical Equipment Group Ltd.
Model
1mL LS
Published
2021-03-29
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
FMFSyringe, Piston
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163161000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163161000Sterile Single-use Syringe with NeedleJiangxi Hongda Medical Equipment Group , Ltd.2017-03-20FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16920756728496PackageGS1100In Commercial Distribution
26920756728493PackageGS136In Commercial Distribution
06920756728499PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1692075672849616920756728496
2692075672849326920756728493
06920756728499069207567284996920756728499

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
526963345
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16920756761905Medical Nitrile Examination Gloves (Power free, Blue)XL2021-08-31
16920756761912Medical Nitrile Examination Gloves (Power free, Blue)XL2021-08-31
16920756761929Medical Nitrile Examination Gloves (Power free, Blue)L2021-08-31
16920756761936Medical Nitrile Examination Gloves (Power free, Blue)L2021-08-31
16920756761943Medical Nitrile Examination Gloves (Power free, Blue)M2021-08-31
16920756761950Medical Nitrile Examination Gloves (Power free, Blue)M2021-08-31
16920756761967Medical Nitrile Examination Gloves (Power free, Blue)S2021-08-31
16920756761974Medical Nitrile Examination Gloves (Power free, Blue)S2021-08-31
16920756761981Medical Nitrile Examination Gloves (Power free, Blue)XS2021-08-31
16920756761998Medical Nitrile Examination Gloves (Power free, Blue)XS2021-08-31
26920756761902Medical Nitrile Examination Gloves (Power free, Blue)XL2021-08-31
26920756761919Medical Nitrile Examination Gloves (Power free, Blue)XL2021-08-31
26920756761926Medical Nitrile Examination Gloves (Power free, Blue)L2021-08-31
26920756761933Medical Nitrile Examination Gloves (Power free, Blue)L2021-08-31
26920756761940Medical Nitrile Examination Gloves (Power free, Blue)M2021-08-31
26920756761957Medical Nitrile Examination Gloves (Power free, Blue)M2021-08-31
26920756761964Medical Nitrile Examination Gloves (Power free, Blue)S2021-08-31
26920756761971Medical Nitrile Examination Gloves (Power free, Blue)S2021-08-31
26920756761988Medical Nitrile Examination Gloves (Power free, Blue)XS2021-08-31
26920756761995Medical Nitrile Examination Gloves (Power free, Blue)XS2021-08-31

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