Biofill applicator

Basic Information

• Brand Name: Biofill applicator
• Primary DI: 04260170881151
• Version / Model: Single-use Biofill Applicator for body-jet evo and body-jet eco, L=300, for 15 c
• Catalog Number: 580001-5
• Company Name: Human Med AG
• Labeler DUNS: 332719157
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-30
• Public Version: 1
• Public Version Date: 2025-08-07
• Public Version Status: New
• Public Device Record Key: 2311b0ea-ced0-4d3d-9b47-2c1e4c5baaf9

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	878.5040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47625	Surgical irrigation/aspiration tubing set	A collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14260170881158	GS1	cardboard box	5	In Commercial Distribution
Primary	04260170881151	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K082025	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 8 – 35 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 8 – 35 Degrees Celsius