M913, Medikro® Nano

Primary DI
06420099000509
Brand
M913, Medikro® Nano
Company
Medikro Oy
Model
M9487
Published
2018-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
BZGSpirometer, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2

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
06420099000509PackageGS11In Commercial Distribution
06420099000820PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06420099000509064200990005096420099000509
06420099000820064200990008206420099000820

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic spirometerA mains electricity (AC-powered) device designed to measure several or all respiratory-gas volume and flow parameters needed to evaluate basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)]. It is an instrument used in a clinical setting with a mouthpiece and tube attached to a computerized unit to process the data from patient ventilatory efforts, volume and/or flow sensors, a display, and usually a graph recorder. The data are compared to standardized values or the patient's former values to help identify or evaluate chronic pulmonary disorders such as asthma, emphysema, or bronchitis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
369263660
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
06420099000554M9256, SpiroSafe Disposable Flow TransducerM9256-1002018-07-13
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

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