FDA.reportPublic FDA data

MIR

Primary DI
08052990321179
Brand
MIR
Company
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Model
FlowMIR
Published
2024-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
BYPMouthpiece, Breathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYPMouthpiece, BreathingAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08052990321179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052990321179080529903211798052990321179

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

Regulatory Flags#

DUNS number
630129930
Device count
1
Premarket exempt
true
Lot or batch
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
06420099000264M9242-100, SpiroSafe Disposable Flow TransducerMedikro OyBYP2026-04-21
06420099000318703419 Disposable Flow Transducer QTY 100Medikro OyBYP2026-04-21
06420099000325703418 Disposable Flow Transducer QTY 25Medikro OyBYP2026-04-21
06420099000332703417 Disposable Flow Transducer QTY 4Medikro OyBYP2026-04-21
06420099000622M9242-SP-90, SpiroSafe Disposable Flow TransducerMedikro OyBYP2026-04-21
08904461055031OSSEOUS-SnorOFFEON MEDITECH PRIVATE LIMITEDBYP2026-03-13
08904461055024OSSEOUS-SnorOFFEON MEDITECH PRIVATE LIMITEDBYP2026-03-13
06923980103674N/AGaleMed Xiamen Co., Ltd.BYP2025-12-23
46923980103672N/AGaleMed Xiamen Co., Ltd.BYP2025-12-23
10197344011315HUDSON RCIMEDLINE INDUSTRIES, INC.BYP2025-08-18
20197344011312HUDSON RCIMEDLINE INDUSTRIES, INC.BYP2025-08-18
14250892907373JaegerJaeger Medical GmbHBYP2025-06-02
14250892908080JaegerJaeger Medical GmbHBYP2025-06-02
34250892907360JaegerJaeger Medical GmbHBYP2025-06-02
10889483573457AirLife™AIRLIFEBYP2025-03-27
10889483569160AirLife™AIRLIFEBYP2025-03-18
10889483569191AirLife™AIRLIFEBYP2025-03-18
00817081028225Mouthpiece, Disposable, White, Thermoplastic, Bite Block StyleA-M SYSTEMS, LLCBYP2025-02-21
00817081028249Breathebite Mouthpiece, Disposable, Thermoplastic, Tongue DepressingA-M SYSTEMS, LLCBYP2025-02-21
07613365500127SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
07613365500141SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
07613365500202SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
20197344120342HUDSON RCIMEDLINE INDUSTRIES, INC.BYP2024-12-10
04719873130191Aerogen®GoHCMED INNOVATIONS CO., LTD.BYP2024-08-20
20197344103734MEDLINEMEDLINE INDUSTRIES, INC.BYP2024-07-22
B279F0370050Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
B279F0370200Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
B279S298070050Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
B279S298070200Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
00384620000733InFloConeALLIANCE TECH MEDICAL INCBYP2023-09-08