FDA.reportPublic FDA data

NA

Primary DI
B207500434100
Brand
NA
Company
BENSON MEDICAL INSTRUMENTS COMPANY
Model
500434-100
Catalog number
NA
Device description
U-tube Mouthpieces
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZGSpirometer, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123896000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123896000CCS-200 SPIROMETERBenson Medical Instruments Co.2013-09-10BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B207500434100PrimaryHIBCC0
B2075004341001Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Breathing mouthpiece, single-useA device designed to be inserted into a patient's mouth 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 provides an appropriate gastight seal (i.e., with a patient's lips) 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). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
612-827-2222TECHSUPPORT@BENSONMEDICAL.COM

Regulatory Flags#

DUNS number
957930696
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B207500326100NA500326-100500326-1002016-10-22
B2075003470NACCS-200NA2016-09-16
B2075002960NANEXTNA2016-09-16
B2075003030NACCA-200MNA2016-09-16
B2075003070NACCA-100MNA2016-09-16
B2075003220NASMART TONENA2016-09-16
B2075004420Benson Medical Instruments Co.CCF200NA2017-05-01

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