FDA.reportPublic FDA data

CareSens™ Pen Needle

Primary DI
08800186704226
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
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
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.

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
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