Active Forward

GUDID 00850015109058

Active Forward Twist Top Lancets, 30 Gauge | Box of 100 Sterile Lancets

OWELL

Blood lancet, single-use

• Primary Device ID: 00850015109058
• NIH Device Record Key: 99306b9e-ff4a-4dc0-8d7e-ab3464c89636
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Active Forward
• Version Model Number: MED-AF-TL-30g-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	00850015109058 [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 [Active Forward]

• 00850015109041: Active Forward Lancing Device With Ejector
• 00850015109058: Active Forward Twist Top Lancets, 30 Gauge | Box of 100 Sterile Lancets