Kit, Reusable Turbine With Mouthpiece, For MIR SmartOne

Basic Information

• Brand Name: Kit, Reusable Turbine With Mouthpiece, For MIR SmartOne
• Primary DI: 00817081025446
• Version / Model: Kit, Reusable Turbine With Mouthpiece - 180001
• Catalog Number: 180001
• Company Name: A-M SYSTEMS, LLC
• Labeler DUNS: 020275145
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-09
• Public Version: 3
• Public Version Date: 2020-12-04
• Public Version Status: Update
• Public Device Record Key: cb54500c-9ee5-49d7-b83a-9c9d903527b7

Device Description

Kit, Reusable Turbine With Mouthpiece, For MIR SmartOne

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
BYP	Mouthpiece, Breathing	Anesthesiology	868.5620	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43467	Breathing mouthpiece, reusable	A device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. The device accepts or attaches to, either directly or through other tubes/adapters, diagnostic/therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser). Some types generate a whistling sound to guide effective inhalation [e.g., during use of a metered dose inhaler (MDI)]. This is a reusable device which may be intended for single- or multi-patient use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00817081025453	GS1		1	In Commercial Distribution
Primary	00817081025446	GS1

Customer Contacts

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