FDA.reportPublic FDA data

One+Step INSULIN PEN NEEDLE

Primary DI
16958697622214
Brand
One+Step INSULIN PEN NEEDLE
Company
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
Model
"32G×5/32"" RWLB"
Device description
"One+Step INSULIN PEN NEEDLE 32G×5/32"" RWLB"
Published
2026-05-15
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
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230043000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230043000Insulin Pen NeedleAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2023-09-20FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26958697622211PackageGS15000In Commercial Distribution
16958697622214PrimaryGS10
06958697622217Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2695869762221126958697622211
1695869762221416958697622214
06958697622217069586976222176958697622217

GMDN Terms#

Term, Definition table
TermDefinition
Autoinjector needleA device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.

Regulatory Flags#

DUNS number
543007373
Device count
100
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
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
06958697621746INSULIN PEN NEEDLE31G x 8mm RWLB2026-03-26

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Primary DI, Brand, Company table
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