FDA.reportPublic FDA data

Insulin Pen Needle

Primary DI
06949236200164
Brand
Insulin Pen Needle
Company
Berpu Medical Technology Co.,Ltd
Model
0.33×8mm
Published
2016-09-15
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06949236200348PackageGS1100In Commercial Distribution
06949236200522PackageGS150In Commercial Distribution
06949236200164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06949236200348069492362003486949236200348
06949236200522069492362005226949236200522
06949236200164069492362001646949236200164

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
529239746
Device count
1
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
06949236203493safety hypodermic needles"18Gx1""(1.2x25mm)"2022-11-21
06949236203509safety hypodermic needles"18Gx1 1/2""(1.2x38mm)"2022-11-21
06949236203516safety hypodermic needles"20Gx1""(0.9x25mm)"2022-11-21
06949236203523safety hypodermic needles"21Gx1""(0.8x25mm)"2022-11-21
06949236203530safety hypodermic needles"21Gx1 1/2""(0.8x38mm)"2022-11-21
06949236203547safety hypodermic needles"22Gx1""(0.7x25mm)"2022-11-21
06949236203554safety hypodermic needles"22Gx1 1/2""(0.7x38mm)"2022-11-21
06949236203561safety hypodermic needles"23Gx1""(0.6x25mm)"2022-11-21
06949236203578safety hypodermic needles"25Gx5/8""(0.5x16mm)"2022-11-21
06949236203585safety hypodermic needles"25Gx1""(0.5x25mm)"2022-11-21
06949236203592safety hypodermic needles"27Gx1/2""(0.4x13mm)"2022-11-21
06949236203608safety hypodermic needles"30Gx1/2""(0.31x13mm)"2022-11-21
16949236203490safety hypodermic needles18Gx1"(1.2x25mm)2022-11-21
16949236203506safety hypodermic needles18Gx1 1/2"(1.2x38mm)2022-11-21
16949236203513safety hypodermic needles20Gx1"(0.9x25mm)2022-11-21
16949236203520safety hypodermic needles21Gx1"(0.8x25mm)2022-11-21
16949236203537safety hypodermic needles21Gx1 1/2"(0.8x38mm)2022-11-21
16949236203544safety hypodermic needles22Gx1"(0.7x25mm)2022-11-21
16949236203551safety hypodermic needles22Gx1 1/2"(0.7x38mm)2022-11-21
16949236203568safety hypodermic needles23Gx1"(0.6x25mm)2022-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M6898250403050MEDIC ENHANCEMENT SETSafeguard US Operating, LLCFMI2026-06-03
08056999020279SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020286SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020293SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020309SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020316SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020323SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020330SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020347SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020354SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020361SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020385SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020408SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
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