Active Forward

GUDID 00850015109041

Active Forward Lancing Device With Ejector

OWELL

Blood glucose/blood pressure monitoring system, home-use

• Primary Device ID: 00850015109041
• NIH Device Record Key: 0cfeffd3-9aed-484f-91d1-0cbd3418ea9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Active Forward
• Version Model Number: Lancing Device With Ejector
• Company DUNS: 123151704
• Company Name: OWELL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00850015109041 [Primary]

FDA Product Code

• FMK: Single Use Only Blood Lancet With 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: 2025-08-13
• Device Publish Date: 2025-08-05

Devices Manufactured by OWELL

• 00850044855308 - OWELL: 2025-08-14 OWELL Safety Lancets | 30g - 1.5mm | 100ct
• 00850044855315 - OWELL: 2025-08-14 OWELL Safety Lancets | 26g - 1.8mm | 100ct
• 00850044855322 - OWELL: 2025-08-14 OWELL Safety Lancets | 23g - 2.2mm | 100ct
• 00850044855339 - OWELL: 2025-08-14 OWELL Safety Lancets | 21g - 2.5mm | 100ct
• 00850015109041 - Active Forward: 2025-08-13Active Forward Lancing Device With Ejector
• 00850015109041 - Active Forward: 2025-08-13 Active Forward Lancing Device With Ejector
• 00850044855025 - OWELL: 2025-08-13 OWELL Lancing Device With Ejector