Biofill applicator 580001-5

GUDID 14260170881158

Biofill applicator, accessory for body-jet evo/eco; suitable for Biofill cannulas (15 cm), Single-use

Human Med AG

Surgical irrigation/aspiration tubing set

• Primary Device ID: 14260170881158
• NIH Device Record Key: 2311b0ea-ced0-4d3d-9b47-2c1e4c5baaf9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biofill applicator
• Version Model Number: Single-use Biofill Applicator for body-jet evo and
• Catalog Number: 580001-5
• Company DUNS: 332719157
• Company Name: Human Med AG
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49385395700
• Email: info@humanmed.com
• Phone: +49385395700
• Email: info@humanmed.com
• Phone: +49385395700
• Email: info@humanmed.com
• Phone: +49385395700
• Email: info@humanmed.com
• Phone: +49385395700
• Email: info@humanmed.com
• Phone: +49385395700
• Email: info@humanmed.com
• Phone: +49385395700
• Email: info@humanmed.com
• Phone: +49385395700
• Email: info@humanmed.com
• Phone: +49385395700
• Email: info@humanmed.com
• Phone: +49385395700
• Email: info@humanmed.com
• Phone: +49385395700
• Email: info@humanmed.com
• Phone: +49385395700
• Email: info@humanmed.com
• Phone: +49385395700
• Email: info@humanmed.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 8 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 8 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 8 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 8 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 8 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 8 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 8 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 8 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 8 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 8 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 8 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 8 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 8 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 8 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260170881151 [Primary]
GS1	14260170881158 [Package]; Contains: 04260170881151; Package: cardboard box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082025

FDA Product Code

• QPB: System, Suction, Lipoplasty For Removal

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: 2025-08-07
• Device Publish Date: 2025-07-30

Devices Manufactured by Human Med AG

• 14260170880045 - WAL applicator: 2025-08-07 WAL applicator, accessory for body-jet; suitable for WAL cannulas (30 cm), Single-use
• 04260170880352 - Hydrophobic Filter-set: 2025-08-07 Hydrophobic Filter-set for body-jet and body-jet eco overflow protection
• 14260170880502 - WAL applicator: 2025-08-07 WAL applicator, accessory for body-jet; suitable for WAL cannulas (20 cm), Single-use
• 04260170880802 - WAL Infiltration Cannula: 2025-08-07 WAL Infiltration Cannula, Ø=3,5mm, L=30cm, Single-use, 0 Holes, Infiltration
• 04260170880819 - WAL Cannula: 2025-08-07 WAL Cannula, Ø=3,8mm, 4 Holes, L=30cm, Single-use, Extraction
• 04260170880840 - WAL Infiltration Cannula: 2025-08-07 WAL Infiltration Cannula, Ø=2,5mm, L=30cm, 0 Holes, Single-use, Infiltration
• 04260170880857 - WAL Cannula: 2025-08-07 WAL Cannula, Ø=4,8mm, 4 Holes, L=30cm, Single-use, Extraction
• 04260170880871 - WAL Cannula: 2025-08-07 WAL Cannula, Ø=4,2mm, 4 Holes, L=30cm, Single-use, Extraction