Suction Catheter Kit

Basic Information

• Brand Name: Suction Catheter Kit
• Primary DI: 00848530082062
• Version / Model: TRATK108
• Catalog Number: TRATK108
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Labeler DUNS: 141668116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-31
• Public Version: 1
• Public Version Date: 2018-08-31
• Public Version Status: New
• Public Device Record Key: 598c5fca-be6b-4d55-8eed-df097095044d

Device Description

This kit includes: 1 Catheter - 8Fr, Y-Valve, 1 Pair gloves - One size fits most.

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
40249	Tracheostomy suction kit	A collection of sterile devices and supplies intended to suction secretions from the trachea and bronchi through a tracheostomy tube. It typically includes a tracheal suctioning catheter with an appropriate tip (e.g., a whistle tip for adults, a smaller one for children) and a thumb operated valve, a pair of gloves, and a container for the aspirates. It is typically intended to be used with a suction machine. Some types include an inner cannula replacement for the tracheostomy tube. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848530082062	GS1
Package	10848530082069	GS1		50	In Commercial Distribution
Package	20848530082066	GS1		4	In Commercial Distribution

Customer Contacts

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