500326-100

GUDID B207500326100

U-tube Mouthpieces

BENSON MEDICAL INSTRUMENTS COMPANY

Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use

• Primary Device ID: B207500326100
• NIH Device Record Key: de292d69-a016-43d3-9584-a5f0add99190
• Commercial Distribution Discontinuation: 2017-06-30
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 500326-100
• Catalog Number: 500326-100
• Company DUNS: 957930696
• Company Name: BENSON MEDICAL INSTRUMENTS COMPANY
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B207500326100 [Primary]
HIBCC	B2075003261001 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123896

FDA Product Code

• BZG: Spirometer, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-23
• Device Publish Date: 2016-10-22

Devices Manufactured by BENSON MEDICAL INSTRUMENTS COMPANY

• B207500326100 - NA: 2020-03-23U-tube Mouthpieces
• B207500326100 - NA: 2020-03-23 U-tube Mouthpieces
• B207500434100 - NA: 2020-03-23 U-tube Mouthpieces
• B2075003470 - NA: 2018-07-06 SPIROMETER
• B2075002960 - NA: 2018-03-29 AUDIOMETER
• B2075003030 - NA: 2018-03-29 AUDIOMETER
• B2075003070 - NA: 2018-03-29 AUDIOMETER
• B2075003220 - NA: 2018-03-29 AUDIOMETER
• B2075004420 - Benson Medical Instruments Co.: 2018-03-29 Fit Test Audiometer