Replacement Part

Basic Information

• Brand Name: Replacement Part
• Primary DI: 00848530107628
• Version / Model: RP025S
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Labeler DUNS: 141668116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-12
• Public Version: 1
• Public Version Date: 2025-11-20
• Public Version Status: New
• Public Device Record Key: de89b918-7633-443f-8a46-281a86f46aa9

Device Description

LUISA, Astral, V*Home, and Trilogy O2 Quick Connect Straight Adapter, 1/4" Barb - 2/PK

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BYX	Tubing, Pressure And Accessories	Anesthesiology	868.5860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37555	Tracheal pilot tube repair kit	A collection of devices designed to restore the integrity of a damaged endotracheal (ET)/tracheostomy pilot tube when it is no longer maintaining the tracheal cuff pressure. Such a repair can deter the need to replace the entire endotracheal/tracheostomy tube because of a damaged pilot tube. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10848530107625	GS1		15	In Commercial Distribution
Primary	00848530107628	GS1
Package	20848530107622	GS1		20	In Commercial Distribution

Customer Contacts

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