FDA.reportPublic FDA data

HWJECT AUTO-DISABLE SYRINGE

Primary DI
06958697621784
Brand
HWJECT AUTO-DISABLE SYRINGE
Company
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
Model
0.05 mL 26G x 10mm RWLB
Device description
HWJECT AUTO-DISABLE SYRINGE 0.05 mL 26G x 10mm RWLB
Published
2026-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K234024000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234024000HWJECT Auto-disable syringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2024-03-19FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16958697621781PackageGS1100In Commercial Distribution
26958697621788PackageGS12400In Commercial Distribution
06958697621784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695869762178116958697621781
2695869762178826958697621788
06958697621784069586976217846958697621784

GMDN Terms#

Term, Definition table
TermDefinition
Metered-delivery hypodermic syringeA sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.

Regulatory Flags#

DUNS number
543007373
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
16958697622214One+Step INSULIN PEN NEEDLE"32G×5/32"" RWLB"2026-05-15
06958697621555Blood Collection Needle without Needle Holder"25G × 3/4"" RWSB"2026-03-26
06958697621562Blood Collection Needle without Needle Holder"24G × 1"" TWSB"2026-03-26
06958697621579Blood Collection Needle without Needle Holder"23G × 1 1/8"" TWSB"2026-03-26
06958697621586Blood Collection Needle without Needle Holder"22G × 1 1/4"" TWSB"2026-03-26
06958697621593Blood Collection Needle without Needle Holder"21G × 1 1/4"" TWLB"2026-03-26
06958697621609Blood Collection Needle without Needle Holder"20G × 1 2/5"" TWLB"2026-03-26
06958697621616Blood Collection Needle without Needle Holder"19G × 1 1/2"" TWLB"2026-03-26
06958697621623Blood Collection Needle without Needle Holder"18G × 1 1/2"" TWLB"2026-03-26
06958697621630Blood Collection Needle with Needle Holder"25G × 3/4"" RWSB"2026-03-26
06958697621647Blood Collection Needle with Needle Holder"24G × 5/8"" TWSB"2026-03-26
06958697621654Blood Collection Needle with Needle Holder"23G × 1 1/8"" TWSB"2026-03-26
06958697621661Blood Collection Needle with Needle Holder"22G × 1 1/4"" TWSB"2026-03-26
06958697621678Blood Collection Needle with Needle Holder"21G × 1 1/4"" TWLB"2026-03-26
06958697621685Blood Collection Needle with Needle Holder"20G × 1 2/5"" TWLB"2026-03-26
06958697621692Blood Collection Needle with Needle Holder"19G × 1 1/2"" TWLB"2026-03-26
06958697621708Blood Collection Needle with Needle Holder"18G × 1 1/2"" TWLB"2026-03-26
06958697621715INSULIN PEN NEEDLE34G x 4mm RWLB2026-03-26
06958697621722INSULIN PEN NEEDLE33G x 5mm RWLB2026-03-26
06958697621739INSULIN PEN NEEDLE32G x 6mm RWLB2026-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05391530754620Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
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05391530753548Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
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05391530753562Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753579Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753593Polycarbonate syringe -DMC MEDICAL LIMITEDFMF2026-06-01
05391530753609Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753616Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753623Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753647Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753654Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753661Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
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