Mouthpiece

Basic Information

• Brand Name: Mouthpiece
• Primary DI: B279298050K025
• Version / Model: Sense
• Catalog Number: 29-8050K-025
• Company Name: S D I DIAGNOSTICS INC
• Labeler DUNS: 037690120
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 8
• Public Version Date: 2023-07-31
• Public Version Status: Update
• Public Device Record Key: 3c8d5756-8588-4dba-ac1a-7326463993aa
• Distribution End Date: 2023-07-24

Device Description

Mouthpiece

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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
Package	B279298050K100	HIBCC	case	25	Not in Commercial Distribution	2023-07-26
Primary	B279298050K025	HIBCC
Unit of Use	B2798050K0251	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K150515	000