FDA.reportPublic FDA data

M9256, SpiroSafe Disposable Flow Transducer

Primary DI
06420099000554
Brand
M9256, SpiroSafe Disposable Flow Transducer
Company
Medikro Oy
Model
M9256-100
Published
2018-07-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BXPTransducer, Gas Flow
BYPMouthpiece, Breathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXPTransducer, Gas FlowAnesthesiology1
BYPMouthpiece, BreathingAnesthesiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133428000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133428000MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PROMedikro OY2014-05-21BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06420099000554PrimaryGS10
06420099000967Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06420099000554064200990005546420099000554
06420099000967064200990009676420099000967

GMDN Terms#

Term, Definition table
TermDefinition
Breathing mouthpiece, single-useA device designed to be inserted into a patient's mouth to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid plastic hollow device with a shape and structure that provides an appropriate gastight seal (i.e., with a patient's lips) and prevents collapse. It is typically attached, either directly or through other tubes/adaptors, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser, breath collector). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
369263660
Device count
100
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
00732094130348703554 Spirometer Kit (USB)M94682026-04-21
06420099000042M921, Medikro® SpiroStar DXM94702026-04-21
06420099000219703552 Spirometer Kit (Serial)M94712026-04-21
06420099000264M9242-100, SpiroSafe Disposable Flow TransducerM92422026-04-21
06420099000318703419 Disposable Flow Transducer QTY 100M9242-WA2026-04-21
06420099000325703418 Disposable Flow Transducer QTY 25M9242-WA2026-04-21
06420099000332703417 Disposable Flow Transducer QTY 4M9242-WA2026-04-21
06420099000448M929, Medikro® SpiroStar USBM94792026-04-21
06420099000622M9242-SP-90, SpiroSafe Disposable Flow TransducerM92422026-04-21
06420099000677M9227, Nose ClipM92272018-07-13
06420099001117M9256-PCD, Disposable Flow Transducer, 100 pcsM9256-PCD-1002019-11-29
06420099000561M9256, SpiroSafe Disposable Flow TransducerM9256-SP-902018-07-13
06420099000691M91227-25, Medikro® GripM912272018-07-13
06420099000820M913, Medikro® NanoM94872018-07-13
06420099000837M915, Medikro® ProM94882018-07-13
06420099000851M914, Medikro® PrimoM94922018-07-13
06420099001094M915-PCD, PCD Spirometer KitM9488-PCD2019-11-29
06420099001087M915-PCD, PCD Spirometer KitM9488-PCD2019-11-29
06420099001124M9264-PCD-200, Pressure TubeM9264-PCD-2002019-11-29
06420099000387M9474, Medikro® Calibration Syringe, 3000 mlM94742018-07-13

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
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
00384620000757All Flow Valved Insp. MthpcALLIANCE TECH MEDICAL INCBYP2023-09-08