FDA.reportPublic FDA data

CareSens™ Pen Needle

Primary DI
08800186704615
Brand
CareSens™ Pen Needle
Company
W.L. MED CO.,LTD.
Model
P3305
Catalog number
33GX5mm
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
08800186704493PackageGS1100In Commercial Distribution
08800186704509PackageGS11200In Commercial Distribution
08800186704516PackageGS17200In Commercial Distribution
08800186704615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800186704493088001867044938800186704493
08800186704509088001867045098800186704509
08800186704516088001867045168800186704516
08800186704615088001867046158800186704615

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
08800186704530CareSens™ Pen NeedleP291229GX12.7mm2023-08-11
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
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

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Primary DI, Brand, Company table
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