FDA.reportPublic FDA data

Syringe without needle

Primary DI
16958697602438
Brand
Syringe without needle
Company
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
Model
LS - 1ml
Catalog number
SLS1
Device description
A 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.
Published
2021-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MEGSyringe, Antistick

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEGSyringe, AntistickGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190183000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190183000Hypodermic Safety Needle, Hypodermic Safety Needle with SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2019-10-04MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16958697602438PackageGS1100In Commercial Distribution
26958697602435PackageGS132In Commercial Distribution
06958697602431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695869760243816958697602438
2695869760243526958697602435
06958697602431069586976024316958697602431

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543007373
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
false
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
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
10840330704868ProCureTwin Med, LLCMEG2026-05-27
10840330704875ProCureTwin Med, LLCMEG2026-05-27
10840330705544ProCureTwin Med, LLCMEG2026-05-27
10840330705551ProCureTwin Med, LLCMEG2026-05-27
10840330705568ProCureTwin Med, LLCMEG2026-05-27
08800052609204"SHINA SAFETY SYRINGE 1.0cc 23G x 1"""SHINA MED CORPORATIONMEG2026-03-25
08800052609211"SHINA SAFETY SYRINGE 1.0cc 25G x 1"""SHINA MED CORPORATIONMEG2026-03-25
08800052609228"SHINA SAFETY SYRINGE 3.0cc 23G x 1"""SHINA MED CORPORATIONMEG2026-03-25
08800052609235"SHINA SAFETY SYRINGE 3.0cc 25G x 1"""SHINA MED CORPORATIONMEG2026-03-25
09347144013093Metier MedicalMETIER MEDICAL LTDMEG2025-07-08
10850053289627SURGYCOSurgyco LLCMEG2024-08-09
10850053289634SURGYCOSurgyco LLCMEG2024-08-09
10850053289641SURGYCOSurgyco LLCMEG2024-08-09
10850053289665SURGYCOSurgyco LLCMEG2024-08-09
10885380184703MonojectCardinal Health 200, LLCMEG2024-03-26
10885380184987MonojectCardinal Health 200, LLCMEG2024-03-26
10885380184994MonojectCardinal Health 200, LLCMEG2024-03-26
10193489037869MedlineMEDLINE INDUSTRIES, INC.MEG2024-02-01
10612479268705McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2023-11-27
10612479268736McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2023-11-27
10193489037814MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037821MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037838MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037845MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037852MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037890MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037906MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037937MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037944MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037951MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10