CareSens™ Pen Needle 31GX6mm

GUDID 08800186704318

W.L. MED CO.,LTD.

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• Primary Device ID: 08800186704318
• NIH Device Record Key: f0f80fd8-d3f5-4e4c-b84a-b376ccd1fdc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CareSens™ Pen Needle
• Version Model Number: P3106
• Catalog Number: 31GX6mm
• Company DUNS: 694103988
• Company Name: W.L. MED CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800186704318 [Package]; Contains: 08800186704554; Package: Inner Box [100 Units]; In Commercial Distribution
GS1	08800186704325 [Package]; Package: Middle Box [1200 Units]; In Commercial Distribution
GS1	08800186704332 [Package]; Contains: 08800186704325; Package: Carton Box [7200 Units]; In Commercial Distribution
GS1	08800186704554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210748

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-21
• Device Publish Date: 2023-08-11

On-Brand Devices [CareSens™ Pen Needle]

• 08800186704493: P3305
• 08800186704462: P3304
• 08800186704431: P3206
• 08800186704400: P3205
• 08800186704370: P3204
• 08800186704349: P3108
• 08800186704318: P3106
• 08800186704288: P3105
• 08800186704226: P2912
• 08800186704257: P3008