FDA.reportPublic FDA data

Safey Pocket Spirometer

Primary DI
08908014292003
Brand
Safey Pocket Spirometer
Company
SAFEY MEDICAL DEVICES PRIVATE LIMITED
Model
165221
Device description
Safey Pocket Spirometer is a Diagnostic Spirometer which connects to a Mobile Phone to carry out tests. Safey Pocket Spirometer is intended to be used by patients above 5 years of age to perform basic lung function tests under the instruction of a physician or practitioner licensed by law to measure the health of the lung. Pocket Spirometer is intended to be used under Home Healthcare environment.
Published
2022-02-04
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
K201002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201002000Safey Pocket SpirometerSafey Medical Devices Pvt, Ltd.2020-07-30BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08908014292003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08908014292003089080142920038908014292003

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic spirometerAn electrically-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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight300Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure75 KiloPascal100 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+919830455253info@safeymedicaldevices.com

Regulatory Flags#

DUNS number
878291677
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013746407NxGen Peak Flow Meter1652532025-01-27
00860013746414NxGen Pocket Spirometer1652212025-01-27
00198715485813NxGen Peak Flow Meter1652532025-01-27
00198715872873NxGen Pocket Spirometer1652212025-01-27
08908014292010Safey Peak Flow Meter1652532022-02-04

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