Ballard* Mini-BAL Sampling Catheter

Basic Information

• Brand Name: Ballard* Mini-BAL Sampling Catheter
• Primary DI: 00609038111193
• Version / Model: 11119
• Catalog Number: 143
• Company Name: Avanos Medical, Inc.
• Labeler DUNS: 079375431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-24
• Public Version: 2
• Public Version Date: 2023-06-21
• Public Version Status: Update
• Public Device Record Key: f3411860-d061-4f5d-96f9-0a48973435e3

Device Description

BALLARD* Mini-BAL Sampling Catheter

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OYI	Non-bronchoscopic bronchoalveolar lavage catheter	Anesthesiology	868.6810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32158	Tracheobronchial suction/insufflation catheter, dual-lumen	A sterile flexible tube designed for periodic tracheal and pharyngeal mucus aspiration and inflation of the lungs with a flow of gas from its distal tip. It consists of a dual-lumen tube which allows simultaneous suction and insufflation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10609038111190	GS1	CS	5	In Commercial Distribution
Primary	00609038111193	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	13	French