NOVAPLUS Sterile Water for Inhalation, USP

Basic Information

• Brand Name: NOVAPLUS Sterile Water for Inhalation, USP
• Primary DI: 00810083350356
• Version / Model: V7871800002
• Catalog Number: V7871800002
• Company Name: Sensimedical LLC
• Labeler DUNS: 117526048
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-23
• Public Version: 1
• Public Version Date: 2022-07-01
• Public Version Status: New
• Public Device Record Key: fb8d829f-5ab1-4ccd-91e2-7673894cd01a

Device Description

Sterile Water for Inhalation, USP, 2000 mL

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	868.5450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35113	Non-heated respiratory humidifier	A device designed to prevent the drying of airway passages associated with the inhalation of oxygen (O2) by adding water vapour to the dry gas as it is passed through, or more seldom, over water. It typically consists of a graduated container (reservoir) for the water, a top piece that functions as a detachable lid (typically a screw lid with a gastight seal), and a tube that protrudes into the water to divert the gas below the water level. This device, commonly known as a bubble humidifier, does not heat the water. It has connectors: 1) one (e.g., a winged nut) that connects to an oxygen therapy flowmeter; and 2) one to which the patient tubing is connected. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00810083350349	GS1		6	In Commercial Distribution
Primary	00810083350356	GS1

Premarket Submissions

Submission Number	Supplement Number
K881184	000