Medipoint Blood Lancets

GUDID 00098108195728

MediPoint Holdings LLC

Blood lancet, single-use

• Primary Device ID: 00098108195728
• NIH Device Record Key: ea9805fd-e102-409d-ab1b-86691bde8339
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medipoint Blood Lancets
• Version Model Number: 195701000
• Company DUNS: 118797353
• Company Name: MediPoint Holdings LLC
• Device Count: 1000
• 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: 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	00098108019574 [Unit of Use]
GS1	00098108195728 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223480

FDA Product Code

• QRK: Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

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: 2023-02-09
• Device Publish Date: 2023-02-01

On-Brand Devices [Medipoint Blood Lancets]

• 00098108195728: 195701000
• 00098108195711: 19570200