FDA.reportPublic FDA data

CareSens™ Pen Needle

Primary DI
08800186704288
Brand
CareSens™ Pen Needle
Company
W.L. MED CO.,LTD.
Model
P3105
Catalog number
31GX5mm
Published
2023-08-11
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
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
08800186704288PackageGS1100In Commercial Distribution
08800186704295PackageGS11200In Commercial Distribution
08800186704301PackageGS17200In Commercial Distribution
08800186704547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800186704288088001867042888800186704288
08800186704295088001867042958800186704295
08800186704301088001867043018800186704301
08800186704547088001867045478800186704547

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
694103988
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
true
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
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
08800186704615CareSens™ Pen NeedleP330533GX5mm2023-08-11
08800186704257CareSens™ Pen NeedleP300830GX8mm2023-08-11
08800186704226CareSens™ Pen NeedleP291229GX12.7mm2023-08-11
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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