NA

Basic Information

• Brand Name: NA
• Primary DI: B207500434100
• Version / Model: 500434-100
• Catalog Number: NA
• Company Name: BENSON MEDICAL INSTRUMENTS COMPANY
• Labeler DUNS: 957930696
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 5
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 1a8d7437-c8b2-49f6-a1d9-059097abaf2b

Device Description

U-tube Mouthpieces

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
44545	Breathing mouthpiece, single-use	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 plastic hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. It is typically attached, either directly or through other tubes/adaptors, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser, breath collector); connectors and filters may be included with the device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B207500434100	HIBCC
Unit of Use	B2075004341001	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K123896	000