FDA.reportPublic FDA data

INSULIN PEN NEEDLE

Primary DI
06958697621777
Brand
INSULIN PEN NEEDLE
Company
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
Model
28G x 12mm RWLB
Device description
INSULIN PEN NEEDLE 28G x 12mm 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
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
16958697621774PackageGS15000In Commercial Distribution
06958697621777PrimaryGS10
26958697621771Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695869762177416958697621774
06958697621777069586976217776958697621777
2695869762177126958697621771

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
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
00840464800019Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800026Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800033Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800040Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800057Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800064Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
10840330704868ProCureTwin Med, LLCFMI2026-05-27
10840330704875ProCureTwin Med, LLCFMI2026-05-27
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044793CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044809CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044816CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044823CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044878CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08800145524667JBP Nanocannula 23Gx40mmFeeltech Co.,Ltd.FMI2026-04-16
08800052609242Sure Fine Pen Needle 32G x 4mmSHINA MED CORPORATIONFMI2026-03-25
08800052609259Sure Fine Pen Needle 31G x 8mmSHINA MED CORPORATIONFMI2026-03-25
08800052609266Sure Fine Pen Needle 32G x 6mmSHINA MED CORPORATIONFMI2026-03-25
08800052609273"Sure Fine Pen Needle 30G x 5/16"""SHINA MED CORPORATIONFMI2026-03-25
08800052609280Sure Fine Pen Needle 31G 5mmSHINA MED CORPORATIONFMI2026-03-25
08800052609297"Sure Fine Pen Needle 29G x 1/2"""SHINA MED CORPORATIONFMI2026-03-25
08720865786063Bella-muU-Needle B.V.FMI2025-10-29
08586015049729SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586015049743SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586015049767SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586026571417SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03