FDA.reportPublic FDA data

MIR

Primary DI
08052990320356
Brand
MIR
Company
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Model
MIR SPIRODOC OXIMETER
Device description
Portable oximeter
Published
2017-04-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103530000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103530000SPIRODOCMedical International Research USA, Inc.2011-11-21BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08052990320356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052990320356080529903203568052990320356

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
06924054300623BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-06-04
06931973410890CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-06-02
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DQA2026-06-02
06920485308450BSXMEDShenzhen BSX Technology Electronics Co., Ltd.DQA2026-06-01
10884521855397NellcorCovidien LPDQA2026-05-29
10884521855403NellcorCovidien LPDQA2026-05-29
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
09551028900069Cables and SensorsXINMED SDN. BHD.DQA2026-04-22
06924054300586BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-04-22
08052990320318MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03