US DIAGNOSTICS

GUDID 00857513006667

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 Blood lancet, single-use

• Primary Device ID: 00857513006667
• NIH Device Record Key: f9268aaf-77ca-4780-b2d0-5a647230cc76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: US DIAGNOSTICS
• Version Model Number: LD-F-II
• Company DUNS: 421330121
• Company Name: Shandong Lianfa Medical Plastic Products 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: 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	00857513006667 [Primary]

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: 2023-06-26
• Device Publish Date: 2023-06-16

On-Brand Devices [US DIAGNOSTICS]

• 00885502007029: Sterile Lancets 30G
• 56949517070399: Single-Use Safety Lancets, 28G, 100/box
• 00857513006667: LD-F-II