Mouthpiece

Basic Information

• Brand Name: Mouthpiece
• Primary DI: B279S298050300
• Version / Model: Sense
• Catalog Number: 29-8050-300
• Company Name: S D I DIAGNOSTICS INC
• Labeler DUNS: 037690120
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 300
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 7
• Public Version Date: 2020-12-04
• Public Version Status: Update
• Public Device Record Key: 8f42ab83-0105-467e-b41d-ef333927c5d4

Device Description

Mouthpiece

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: 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
BZG	Spirometer, Diagnostic	Anesthesiology	868.1840	2

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
Primary	B279S298050300	HIBCC
Unit of Use	B279S2980503003	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K150515	000