ChoiceMMed

Basic Information

• Brand Name: ChoiceMMed
• Primary DI: 00846841030147
• Version / Model: MD8000
• Company Name: Beijing Choice Electronic Technology Co., Ltd.
• Labeler DUNS: 526882823
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-13
• Public Version: 1
• Public Version Date: 2020-08-21
• Public Version Status: New
• Public Device Record Key: 31688640-64da-42ca-a0f2-0c856c51638b

Device Description

ChoiceMMed LungBoost Respiratory Trainer MD8000

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Lot/Batch Number: No
• 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
ION	Exerciser, Non-Measuring	Physical Medicine	890.5370	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43017	Respiratory muscle training mask	A mask placed over the nose/mouth designed to create resistance for a patient's airway while inhaling and/or exhaling during respirations to strengthen and rehabilitate the respiratory muscles. It typically creates resistance through a mechanical means (e.g., a spring-loaded valve) that can be adjusted to provide progressive training. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00846841030147	GS1