FDA.reportPublic FDA data

Spirometer

Primary DI
06934325302294
Brand
Spirometer
Company
FEELLIFE HEALTH INC.
Model
Air Smart Extra
Published
2023-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
BZGSpirometer, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222443000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222443000Air Smart Extra SpirometerFeellife Health, Inc.2023-08-09BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06934325302294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934325302294069343253022946934325302294

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic spirometer, professionalAn electrically-powered device designed exclusively for professional use to measure several or all respiratory gas volume and flow parameters for evaluation of basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)]; it may also perform pulse oximetry. It is typically a hand-held instrument with a mouthpiece which communicates with a computerized unit (e.g., analysis system, graph recorder, tablet). It is used to help diagnosis and monitoring of chronic pulmonary disorders such as asthma, emphysema, or bronchitis, and potentially heart disorders.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544431678
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06934325302249Portable Mesh NebulizerAir Mask D2023-02-08
06934325302263Portable Mesh NebulizerAirICU2023-02-08
06934325301846Portable Mesh NebulizerAir Plus2022-10-08
06934325303741MouthpieceMP12023-02-14
06934325303758Disposable MouthpieceDM12023-02-14
06934325303765Pressure gas blowpipePB12023-02-14
06934325322278Portable Mesh NebulizerAir Kids2021-08-19
06934325338705Portable Mesh NebulizerAir Pro VIII2021-08-19
06934325376950Portable Mesh NebulizerAerogo2021-08-19
06934325319490Portable Mesh NebulizerAeroCentre+2021-08-19
06934325349237Portable Mesh NebulizerAir Pro III2021-08-19
06934325358475Portable Mesh NebulizerAir Pro2021-08-19
06934325371733Portable Mesh NebulizerAir Mask II2021-08-19
06934325380353Portable Mesh NebulizerAir Pro IX2021-08-19
06934325388540Portable Mesh NebulizerAir Angel2021-08-19

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Primary DI, Brand, Company table
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