SYSTEM 22

Basic Information

• Brand Name: SYSTEM 22
• Primary DI: 00383730004259
• Version / Model: 0
• Catalog Number: 1050430
• 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: 2017-04-19
• Public Version: 4
• Public Version Date: 2020-11-19
• Public Version Status: Update
• Public Device Record Key: 30eb0e82-664f-4511-904c-21a5fe6bf1ff

Device Description

SYSTEM 22 PEDIATRIC AEROSOL MSK SUB ASSY

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
BYG	MASK, OXYGEN	Anesthesiology	868.5580	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35142	Aerosol face mask, rebreathing, single-use	A flexible, form-shaped device that is placed over the nose and mouth to deliver aerosolized particles/gases to a patient's airway. It is typically used in conjunction with a nebulizer or medicine chamber spacer for the delivery of medication in either a healthcare or home setting. It is made of high-grade resins or other materials to produce a soft, flexible mask that will create an airtight seal against the patient's face. It may include a headstrap and is available in a range of sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00383730004259	GS1

Customer Contacts

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