FDA.reportPublic FDA data

MIR

Primary DI
08052990320523
Brand
MIR
Company
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Model
MIR SPIROTEL SPIROMETER WITH BLUETOOTH
Device description
Portable spirometer for lung function testing
Published
2017-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZGSpirometer, Diagnostic
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130784000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130784000SPIROTELMir Medical Intl. Research Srl2013-10-30BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08052990320523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052990320523080529903205238052990320523

GMDN Terms#

Term, Definition table
TermDefinition
Expiratory peak flow meter, digitalA battery-powered, hand-held, electronic instrument designed to measure the maximum rate of expiratory gas flow [peak expiratory flow (PEF) or peak expiratory flow rate (PEFR)] and forced expiratory volume (FEV) from the lungs. It typically includes a mouthpiece for patient exhalation and a digital display [e.g., liquid-crystal display (LCD)]; it may include a port for communicating with a computer/tablet. The device is typically intended to monitor the respiratory status of a patient affected by chronic respiratory disorders (e.g., asthma, emphysema) in a clinical setting or the home.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+390622754777gerda.v@spirometry.com

Regulatory Flags#

DUNS number
630129930
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08052990320288MIRSpirolab PLUS ESI2026-04-03
08052990320295MIRSpirolab PLUS ESI2026-04-03
08052990320318MIRSpirolab PLUS ESI2026-04-03
08052990320325MIRSpirolab PLUS ESI2026-04-03
08052990320363MIRMiniSpir PLUS2026-04-03
08052990320370MIRMiniSpir PLUS2026-04-03
08052990320387MIRSpirobank II PLUS2026-04-03
08052990320431MIRMiniSpir PLUS ESI2026-04-03
08052990320455MIRSpirobank II Light2026-04-03
08052990320462MIRSpirobank II Light2026-04-03
08052990320479MIRSpirobank II PLUS2026-04-03
08052990320509MIRSpirobank II PLUS2026-04-03
08052990320516MIRSpirobank II PLUS2026-04-03
08052990320547MIRSpirolab PLUS2026-04-03
08052990320554MIRSpirolab PLUS2026-04-03
08052990320561MIRSpirolab PLUS2026-04-03
08052990320585MIRSpirolab PLUS2026-04-03
08052990322022MIRMiniSpir PLUS ESI2026-04-03
08052990320608MIRMiniSpir PLUS ESI2025-12-19
08052990320615MIRMiniSpir PLUS ESI2025-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00093351041099N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013550N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013567N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113849N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06931973400563CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400730CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400785CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410326CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410333CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410340CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410364CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410371CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410388CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410395CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410401CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410418CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410425CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410432CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410449CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410456CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410647CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410678CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410685CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410692CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410715CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410722CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410739CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410746CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09