Respiratory Accessory

Basic Information

• Brand Name: Respiratory Accessory
• Primary DI: 00848530100506
• Version / Model: RES013-10-10
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Labeler DUNS: 141668116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-14
• Public Version: 1
• Public Version Date: 2024-06-24
• Public Version Status: New
• Public Device Record Key: 9371eb38-d797-406e-956d-65f8fd30d7fb

Device Description

Circuit Connector 22mm O.D./15mm I.D. x 22mm O.D. - (10 packs of 10ea)

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
BZA	Connector, Airway (Extension)	Anesthesiology	868.5810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62966	Artificial airway cuff inflation tubing	A length of flexible tube designed to connect cuff inflation devices to deliver air during inflation of the cuff of an endotracheal (ET)/ tracheostomy tube. It typically includes connectors at each end. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848530100506	GS1

Customer Contacts

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