TysonBio

GUDID 06949517006362

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: 06949517006362
• NIH Device Record Key: f4d0f2d2-a50f-4f4c-ae1f-3b77ebeeaf10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TysonBio
• Version Model Number: LF-TL-30
• 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: 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	06949517006362 [Primary]
GS1	56949517070788 [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: 2023-07-24
• Device Publish Date: 2023-07-15

On-Brand Devices [TysonBio]

• 56949517070863: LF-TL-30
• 06949517006430: LF-TL-30
• 56949517070849: LF-TL-30
• 56949517070832: LF-TL-30
• 56949517070825: LF-TL-30
• 56949517070818: LF-TL-30
• 56949517070801: LF-TL-28
• 06949517006362: LF-TL-30