FDA.reportPublic FDA data

CareSens™ Pen Needle

Primary DI
08800186704530
Brand
CareSens™ Pen Needle
Company
W.L. MED CO.,LTD.
Model
P2912
Catalog number
29GX12.7mm
Published
2023-08-11
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
K210748000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210748000Well-life TM Pen Needles, Well-life TM Safety Pen NeedlesW. L. Med Co., Ltd.2022-05-25FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800186704226PackageGS1100In Commercial Distribution
08800186704233PackageGS11200In Commercial Distribution
08800186704240PackageGS17200In Commercial Distribution
08800186704530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800186704226088001867042268800186704226
08800186704233088001867042338800186704233
08800186704240088001867042408800186704240
08800186704530088001867045308800186704530

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
694103988
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
08800186704523CareSens™ Pen NeedleP300830GX8mm2023-08-11
08800186704547CareSens™ Pen NeedleP310531GX5mm2023-08-11
08800186704554CareSens™ Pen NeedleP310631GX6mm2023-08-11
08800186704561CareSens™ Pen NeedleP310831GX8mm2023-08-11
08800186704578CareSens™ Pen NeedleP320432GX4mm2023-08-11
08800186704585CareSens™ Pen NeedleP320532GX5mm2023-08-11
08800186704592CareSens™ Pen NeedleP320632GX6mm2023-08-11
08800186704608CareSens™ Pen NeedleP330433GX4mm2023-08-11
08800186704615CareSens™ Pen NeedleP330533GX5mm2023-08-11
08800186704257CareSens™ Pen NeedleP300830GX8mm2023-08-11
08800186704226CareSens™ Pen NeedleP291229GX12.7mm2023-08-11
08800186704288CareSens™ Pen NeedleP310531GX5mm2023-08-11
08800186704318CareSens™ Pen NeedleP310631GX6mm2023-08-11
08800186704349CareSens™ Pen NeedleP310831GX8mm2023-08-11
08800186704370CareSens™ Pen NeedleP320432GX4mm2023-08-11
08800186704400CareSens™ Pen NeedleP320532GX5mm2023-08-11
08800186704431CareSens™ Pen NeedleP320632GX6mm2023-08-11
08800186704462CareSens™ Pen NeedleP330433GX4mm2023-08-11
08800186704493CareSens™ Pen NeedleP330533GX5mm2023-08-11

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