FDA.reportPublic FDA data

EasyOne Diagnostic Spirometer

Primary DI
07640142190042
Brand
EasyOne Diagnostic Spirometer
Company
NDD Medizintechnik AG
Model
2001-1
Catalog number
2001-1
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K993921000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993921000NDD MEDICAL TECHNOLOGIES EASYONE SPIROMETER: FRONTLINE MODEL 2000 AND DIAGNOSTIC MODEL 2001Ndd Medical Technologies2000-05-23BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640142190042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640142190042076401421900427640142190042

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(978) 470-0923customerservice@nddmed.com
+41444452530info@ndd.ch

Regulatory Flags#

DUNS number
487451916
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640142190554EasyOne Sky Spirometer2800-12026-04-21
07640142190653spirette FA Pro/LAB2050-722023-06-23
07640142190608Filter Adapter SP2030-112023-06-22
07640142190615Filter Adapter FT2030-212023-06-22
07640142190233spirette2050-12023-06-23
07640142190240spirette2050-52023-06-23
07640142190271spirette m2050-72023-06-23
07640142190660spirette FA Pro/LAB2050-712023-06-23
07640142190684spirette FA Pro/LAB2050-732023-06-23
07640142190677spirette m2050-72023-06-23
07640142190479Spiro-SP TrueFlow Sensor2700-1SP2023-06-23
07640142190646spirette FA Pro/LAB2050-732023-06-23
07640142190400spirette2050-102023-06-22
07640142190448EasyOne FlowTube5050-502023-06-22
07640142190455EasyOne FlowTube5050-2002023-06-22
07640142190486spirette2050-102023-06-22
07640142190516EasyOne FlowTube5050-2002023-06-22
07640142190462EasyOne FlowTube5050-5002023-06-22
07640142190561Filter Adapter SP2030-112023-06-22
07640142190578Filter Adapter FT2030-212023-06-22

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Primary DI, Brand, Company table
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