ASEPT®

Basic Information

• Brand Name: ASEPT®
• Primary DI: 04046964317200
• Version / Model: 622279
• Catalog Number: 622279
• Company Name: B BRAUN INTERVENTIONAL SYSTEMS, INC
• Labeler DUNS: 784259751
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-08-09
• Public Version: 7
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 04c2375c-c5dc-4af4-b933-a335ad066d87

Device Description

ASEPT 1000ML BOTTLE W/ PACK

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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
DWM	APPARATUS, SUCTION, PATIENT CARE	Cardiovascular	870.5050	2
KDQ	BOTTLE, COLLECTION, VACUUM	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11301	Closed-wound/centesis drainage receptacle	A sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046964317200	GS1
Unit of Use	04046964317187	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	1000.0	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: KEEP DRY
• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temp
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight
• Type: Special Storage Condition, Specify