ASEPT

Basic Information

• Brand Name: ASEPT
• Primary DI: 04046955911493
• Version / Model: 622282
• Catalog Number: 622282
• Company Name: B. BRAUN MEDICAL INC.
• Labeler DUNS: 002397347
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2025-10-14
• Public Version: 1
• Public Version Date: 2025-10-22
• Public Version Status: New
• Public Device Record Key: c6a6b404-1181-4d00-8f87-dc23d67ab569

Device Description

ASEPT 1000ML BOTTLE STARTER KIT, 4PK

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• 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
PXU	Fluid drainage tray	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62850	Wound drainage bag	A plastic pouch designed to be attached with an adhesive to the skin around a large wound or fistula and intended to be used as a receptacle for exudate, blood, or other bodily wastes. It is a one-piece device, supplied in a variety of sizes, with a large-area adhesive flange that can be cut to fit closely around a wound, and which may provide some skin protection. It may have a tubular outlet and be connected to a drain system; it does not include accessory devices (i.e., not a kit). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	04046955911486	GS1
Primary	04046955911493	GS1

Customer Contacts

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