FDA.reportPublic FDA data

Micro Medical

Primary DI
54250892980091
Brand
Micro Medical
Company
CAREFUSION U.K. 232 LIMITED
Model
36-ML3535 MK8-REGION 2&3
Catalog number
36-ML3535 MK8-REGION 2&3
Device description
MicroLoop
Published
2016-08-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZGSpirometer, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54250892980091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5425089298009154250892980091

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+499314972127support.rt.eu@carefusion.com

Regulatory Flags#

DUNS number
291555621
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
34250892980196Micro Medical36-SST100036-SST10002017-04-06
34250892980202Micro Medical36-SST125036-SST12502017-04-06
34250892980219Micro Medical36-PSA100036-PSA10002017-04-06
34250892980226Micro Medical36-PSA120036-PSA12002017-04-06
54250892980022Micro Medical36-MD03-STK36-MD03-STK2016-08-04
54250892980039Micro Medical36-ML2525-STK36-ML2525-STK2016-08-04
54250892980046Micro Medical36-ML3500 MK8-STK36-ML3500 MK8-STK2016-08-04
54250892980053Micro Medical36-ML3500 MK8-REGION 2&336-ML3500 MK8-REGION 2&32016-08-04
54250892980060Micro Medical36-ML3500 MK8-REGION436-ML3500 MK8-REGION42016-08-04
54250892980077Micro Medical36-ML3535 MK8-STK36-ML3535 MK8-STK2016-08-04
54250892980084Micro Medical36-PL10-STK/NHANES36-PL10-STK/NHANES2016-08-04
54250892980107Micro Medical36-ML3535 MK8-REGION436-ML3535 MK8-REGION42016-08-04
54250892980114Micro Medical36-MS10-STK36-MS10-STK2016-08-04
54250892980121Micro Medical36-PL10-STK/ECCS36-PL10-STK/ECCS2016-08-04
54250892980152Micro Medical36-PL10-STK/ASIAN36-PL10-STK/ASIAN2016-08-04
14250892980185Micro Medical36-MTH641036-MTH64102017-04-06
54250892980145Micro Medical36-SC01-STK36-SC01-STK2016-09-26
34250892980233Spirometry PC Software2.536-SPC1000-STK2017-10-27
34250892980257Spirometry PC Software Licence2.536-SPC0105-STK2017-10-27
34250892980264Spirometry PC Software Update2.536-SPCU100-STK2017-10-27

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