FDA.reportPublic FDA data

Benson

Primary DI
04260176127772
Brand
Benson
Company
MAICO Diagnostics GmbH
Model
CCS-200 Spirometer
Published
2021-02-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
04260176127772PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260176127772042601761277724260176127772

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260176120148MaicoERO SCAN2020-04-17
04260176128304BensonCCS-200 Spirometer2021-02-15
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

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Primary DI, Brand, Company table
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