Ballard* Closed Suction System

Basic Information

• Brand Name: Ballard* Closed Suction System
• Primary DI: 00609038938264
• Version / Model: 93826
• Catalog Number: 198
• Company Name: Avanos Medical, Inc.
• Labeler DUNS: 079375431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-08
• Public Version: 2
• Public Version Date: 2023-06-21
• Public Version Status: Update
• Public Device Record Key: 60c49df4-2abf-4086-9bda-98b3daa2ea7f

Device Description

BALLARD* Closed Suction Catheter, Y-Adapter, Neonatal/Pediatric

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
BSY	CATHETERS, SUCTION, TRACHEOBRONCHIAL	Anesthesiology	868.6810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34923	Suction system catheter, general-purpose	A sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20609038938268	GS1	CS	2	In Commercial Distribution
Package	10609038938261	GS1	DSP	10	In Commercial Distribution
Primary	00609038938264	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	8	French