BALLARD™

Basic Information

• Brand Name: BALLARD™
• Primary DI: 10889483623213
• Version / Model: 195-4J
• Catalog Number: 195-4J
• Company Name: SUNMED, LLC
• Labeler DUNS: 069009268
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-17
• Public Version: 2
• Public Version Date: 2026-01-16
• Public Version Status: Update
• Public Device Record Key: cf340336-83dd-4106-862e-822cb44dde62

Device Description

BALLARD™ CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS, Y Type 5 F

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
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	30889483623217	GS1	Case	2	In Commercial Distribution
Primary	10889483623213	GS1
Package	20889483623210	GS1	Dispenser	10	In Commercial Distribution
Previous	00609038993126	GS1