FDA.reportPublic FDA data

MEDSUN

Primary DI
16934047902502
Brand
MEDSUN
Company
Ningbo Medsun Medical Co., Ltd.
Model
ST 0.30mm×5mm
Published
2024-08-15
Public version status
Update
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
K221178000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221178000Disposable Insulin Pen NeedleNingbo Medsun Medical Co., Ltd.2022-11-17FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16934047902502PrimaryGS10
06934047902505Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693404790250216934047902502
06934047902505069340479025056934047902505

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
545194383
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
06934047910609MEDSUNDLM2026-04-22
06934047910616MEDSUNDLP2026-04-22
06934047910623MEDSUNDLN2026-04-22
06934047910630MEDSUNDLT2026-04-22
06934047910647MEDSUNELM2026-04-22
06934047910654MEDSUNELP2026-04-22
06934047910661MEDSUNELN2026-04-22
06934047910678MEDSUNELT2026-04-22
06934047910685MEDSUNSD 0.3mm(30G)×4mm2026-04-22
06934047910692MEDSUNSD 0.3mm(30G)×5mm2026-04-22
06934047910708MEDSUNSD 0.3mm(30G)×6mm2026-04-22
06934047910715MEDSUNSD 0.3mm(30G)×8mm2026-04-22
06934047910722MEDSUNSD 0.25mm(31G)×4mm2026-04-22
06934047910739MEDSUNSD 0.25mm(31G)×5mm2026-04-22
06934047910746MEDSUNSD 0.25mm(31G)×6mm2026-04-22
06934047910753MEDSUNSD 0.25mm(31G)×8mm2026-04-22
06934047910760MEDSUNSD 0.22mm(32.5G)×8mm2026-04-22
06934047910777MEDSUNSDW 0.3mm(30G)×4mm2026-04-22
06934047910784MEDSUNSDW 0.3mm(30G)×5mm2026-04-22
06934047910791MEDSUNSDW 0.3mm(30G)×6mm2026-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850091070235CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070242CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070259CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070266CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070273CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070280CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070297CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070303CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070310CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070327CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070334CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070341CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070365CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070433CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00814965020481Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020504Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020528Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020542Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020788Precision PointGold Coast Medical Supply, LPFMI2026-08-26
06972857295677contour comfort Pen NeedleSandstone Medical (Suzhou) Inc.FMI2026-08-19
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00301691863500NOVOFINE PLUS 29GNOVO NORDISK INC.FMI2026-07-31
00301691863906NovoFine® Plus 29GNOVO NORDISK INC.FMI2026-07-31
10192253005066MonojectCardinal Health 200, LLCFMI2026-07-31
10192253005516MonojectCardinal Health 200, LLCFMI2026-07-31
00810094578053Curaplex®BOUND TREE MEDICAL, LLCFMI2026-07-30
10801902215175ARROWTELEFLEX INCORPORATEDFMI2026-07-29