Linkfar

GUDID 56949517070870

Shandong Lianfa Medical Plastic Products CO.,LTD

Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use

• Primary Device ID: 56949517070870
• NIH Device Record Key: b779ffa9-4c28-432a-9a2b-a6e0951f3143
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Linkfar
• Version Model Number: LF-TL-28
• Company DUNS: 421330121
• Company Name: Shandong Lianfa Medical Plastic Products CO.,LTD
• Device Count: 10
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	06949517006546 [Primary]
GS1	56949517070870 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222472

FDA Product Code

• FMK: Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
• QRL: Multiple Use Blood Lancet For Single Patient Use Only

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-27
• Device Publish Date: 2024-03-19

Devices Manufactured by Shandong Lianfa Medical Plastic Products CO.,LTD

• 56949517070757 - Twist Lancet (30G): 2024-04-01 Sterile Lancet for Single Use(Bag 10 lancets), Sterilized with Irradiation
• 56949517070764 - Twist Lancet (30G): 2024-04-01 Sterile Lancet for Single Use(Bag 50 lancets), Sterilized with Irradiation
• 56949517070870 - Linkfar: 2024-03-27
• 56949517070870 - Linkfar: 2024-03-27
• 06949517006362 - TysonBio: 2023-07-24
• 56949517070795 - plusmed: 2023-07-24
• 56949517070801 - TysonBio: 2023-07-24
• 56949517070818 - TysonBio: 2023-07-24
• 56949517070825 - TysonBio: 2023-07-24