OWELL

GUDID 00850044855346

OWELL

Blood lancet, single-use

• Primary Device ID: 00850044855346
• NIH Device Record Key: e2f54290-52d9-4d71-b24b-3b8d57c177c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OWELL
• Version Model Number: OWTL26G-100
• Company DUNS: 123151704
• Company Name: OWELL
• 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: 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	00850044855346 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222472

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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-10
• Device Publish Date: 2025-12-02

On-Brand Devices [OWELL]

• 00850044855025: OWELL Lancing Device With Ejector
• 00850044855339: OWELL Safety Lancets | 21g - 2.5mm | 100ct
• 00850044855322: OWELL Safety Lancets | 23g - 2.2mm | 100ct
• 00850044855315: OWELL Safety Lancets | 26g - 1.8mm | 100ct
• 00850044855308: OWELL Safety Lancets | 30g - 1.5mm | 100ct
• 00850044855476: OWELL Twist Lancets, 33g | 300 Count
• 00850044855421: OWTL30G-50
• 00850044855377: OWTL33G-100
• 00850044855360: OWTL30G-100
• 00850044855353: OWELL Twist Top Lancets, 28g | 100 Count
• 00850044855346: OWTL26G-100