Suction Catheter Kit - Sterile - Includes Gloves, Catheter - 10Fr

Basic Information

• Brand Name: Suction Catheter Kit - Sterile - Includes Gloves, Catheter - 10Fr
• Primary DI: 00848530082079
• Version / Model: TRATK110
• Catalog Number: TRATK110
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Labeler DUNS: 141668116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-17
• Public Version: 1
• Public Version Date: 2018-10-18
• Public Version Status: New
• Public Device Record Key: 0dfb3952-d1df-43de-a64f-a3c86c78d7ee

Device Description

Suction Catheter Kit - Sterile - Includes Gloves, Catheter - 10Fr

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: Yes
• 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
OFS	Tracheal Suction Set	Anesthesiology	868.6810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13846	Secretion suction kit	A collection of items intended for suctioning secretions from a patient; typically included are sterile gloves, a suction catheter, and a container for collecting the secretions. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20848530082073	GS1		4	In Commercial Distribution
Package	10848530082076	GS1		50	In Commercial Distribution
Primary	00848530082079	GS1