MiniBox+

Primary DI
07290016675016
Brand
MiniBox+
Company
PULMONE ADVANCED MEDICAL DEVICES LTD
Model
MiniBox+
Device description
The PulmOne MiniBox+ is intended to measure lung function in adult and pediatric patients, 5 years and older, while at rest (including spirometry, lung volumes and diffusing capacity). The PulmOne MiniBox+ is to be used by a physician, respiratory therapist, or technician in a hospital or clinic setting
Published
2017-01-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BZCCalculator, Pulmonary Function Data
BZGSpirometer, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZCCalculator, Pulmonary Function DataAnesthesiology2
BZGSpirometer, DiagnosticAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161295000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161295000MiniBox +Pulmone Advanced Medical Devices, Ltd.2016-10-21BZC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016675016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016675016072900166750167290016675016

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic spirometerA mains electricity (AC-powered) device designed to measure several or all respiratory-gas volume and flow parameters needed to evaluate basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)]. It is an instrument used in a clinical setting with a mouthpiece and tube attached to a computerized unit to process the data from patient ventilatory efforts, volume and/or flow sensors, a display, and usually a graph recorder. The data are compared to standardized values or the patient's former values to help identify or evaluate chronic pulmonary disorders such as asthma, emphysema, or bronchitis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
514812275
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016675009MiniBoxMiniBoxPUO-MiniBox2016-09-24

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