Responsive Respiratory

Basic Information

• Brand Name: Responsive Respiratory
• Primary DI: 00851440007728
• Version / Model: 220-3210
• Company Name: RESPONSIVE RESPIRATORY, INC.
• Labeler DUNS: 129132747
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2024-08-01
• Public Version: 1
• Public Version Date: 2024-08-09
• Public Version Status: New
• Public Device Record Key: 158945c4-1347-4825-95d7-19bbad08e032

Device Description

Adult Nebulizer Kit w/ Mouthpiece

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: Yes
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	868.5640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31309	Nebulizing system delivery set, single-use	A collection of flexible tubing, typically non-sterile, and associated items that may include a mask or mouthpiece, a medication chamber, and connectors, used with a nebulizer to deliver an aerosol, usually medicated, to the patient's respiratory system. It is made of synthetic material and is typically a thick-walled, anti-kink tubing to prevent blockage. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10851440007725	GS1
Primary	00851440007728	GS1