FDA.reportPublic FDA data

Benson

Primary DI
04260176128304
Brand
Benson
Company
MAICO Diagnostics GmbH
Model
CCS-200 Spirometer
Published
2021-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BZGSpirometer, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260176128304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260176128304042601761283044260176128304

GMDN Terms#

Term, Definition table
TermDefinition
Monitoring spirometer, electricalA mains electricity (AC-powered) device designed to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status. It may also be used to measure the tidal volume, minute volume, and respiration rate delivered to a patient via the expiratory ports of resuscitation devices, such as transport ventilators and resuscitators, to evaluate their performance. The device may incorporate high and low tidal volume alarms.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
344863550
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260176120148MaicoERO SCAN2020-04-17
04260176120902MaicoMA 422020-04-17
04260176128311BensonNEXT Audiometer2021-02-15
04260176120704MaicoMA 412020-04-17
04260176127444MaicoMA 422022-06-15
04260176129431MaicoeasyTone2022-06-15
04260176127628BensonCCA-100 Mini Audiometer2021-02-15
04260176127635BensonCCF-200 Fit Test2021-02-15
04260176127659BensonCCA-200 Mini Audiometer2021-02-15
04260176127666BensonCCA-200 Mini 2021-02-15
04260176127673BensonCCA-200 Mini Audiometer2021-02-15
04260176127697BensonCCA-100 Mini Audiometer2021-02-15
04260176127703BensonCCA-100 Mini Audiometer2021-02-15
04260176127734BensonCCF-200 Fit Tester2021-02-15
04260176127741BensonCCF-200 Fit Tester2021-02-15
04260176127369TREMETRICSRA3602020-07-08
04260176120377MaicoMA 252020-04-17
04260176120858MaicoMA 12020-04-17
04260176120865MaicoMA 272020-04-17
04260176121961MaicoMA 332020-04-17

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Primary DI, Brand, Company table
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