FDA.reportPublic FDA data

EasyOne Pro

Primary DI
07640142190349
Brand
EasyOne Pro
Company
NDD Medizintechnik AG
Model
3000-1
Catalog number
3000-1
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
BTYCalculator, Predicted Values, Pulmonary Function

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTYCalculator, Predicted Values, Pulmonary FunctionAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091428000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091428000EASYONE PRO RESPIRATORY ANALYSIS SYSTEMNdd Medizitechnik AG2010-01-27BTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640142190349PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640142190349076401421903497640142190349

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary function analysis system, adultA device used to measure the function of the respiratory system in adults and compliant children. It usually includes a spirometer with volume-sensing (e.g., rolling-seal, bellow) and flow-sensing (e.g., pneumotachometer) devices, a gas analyser for evaluation of absolute lung volumes and gas-diffusing capacity of the lungs, and computer capabilities for data processing and recording; a total-body plethysmograph to measure both lung volumes and airway resistance may be included. The device is mostly used for outpatient or presurgical screening, and may also be used in the diagnosis and evaluation of common diseases in older children [e.g., asthma, cystic fibrosis (CF), chest deformities].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 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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