ISG Mouthpiece Mask Adapter Assembly

Basic Information

• Brand Name: ISG Mouthpiece Mask Adapter Assembly
• Primary DI: 00383730003849
• Version / Model: 00
• Catalog Number: 1125850
• Company Name: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
• Labeler DUNS: 220018415
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-09
• Public Version: 1
• Public Version Date: 2018-12-10
• Public Version Status: New
• Public Device Record Key: 3d9b1b28-23ec-43c4-9c24-4c724561438f
• Distribution End Date: 2100-12-31

Device Description

ISG Medium Mask and Mask Adapter Assembly

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: Yes
• Has Lot/Batch Number: No
• 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
CAF	NEBULIZER (DIRECT PATIENT INTERFACE)	Anesthesiology	868.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12719	Ultrasonic nebulizing system	An assembly of devices designed to generate aerosolized medication/fluids (finely dispersed airborne droplets) for inhalation by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It typically consists of a mains electricity (AC-powered) electronic oscillator, an ultrasound transducer (piezoelectric crystal), a coupling basin, a nebulizer chamber and a fan. A high frequency (e.g., 1-2 MHz) electrical current is applied to the crystal within the oscillator circuit converting it to vibrations which produce sound waves. The coupler (water or saline) transmits the sound waves to the medicated solution in the nebulizing chamber.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00383730003849	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K170853	000