REMSTAR PASSOVER HUMIDIFIER

Basic Information

• Brand Name: REMSTAR PASSOVER HUMIDIFIER
• Primary DI: 00606959015203
• Version / Model: REMstar Passover Humidifier
• Catalog Number: 1006087
• Company Name: Respironics, Inc.
• Labeler DUNS: 080728314
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-26
• Public Version: 3
• Public Version Date: 2022-10-24
• Public Version Status: Update
• Public Device Record Key: 8923474c-a7fa-435b-a16e-578f8ccd5bd5
• Distribution End Date: 2022-10-21

Device Description

REMSTAR PASSOVER HUMIDIFIER

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
Primary	00606959015203	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K945782	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit