One +Step

GUDID 06949517008878

Shandong Lianfa Medical Plastic Products CO.,LTD

Manual blood lancing device, reusable

• Primary Device ID: 06949517008878
• NIH Device Record Key: f825bf8d-99fc-4755-88e9-fa05ac21b8a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: One +Step
• Version Model Number: LDE
• 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06949517008878 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222472

FDA Product Code

• 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: 2025-07-07
• Device Publish Date: 2025-06-27

On-Brand Devices [One +Step]

• 06949517008878: LDE
• 56949517070917: LF-TL-30-II
• 56949517070900: LF-TL-28-I
• 56949517070894: LF-TL-23-I