FDA.reportPublic FDA data

Spirometry PC Software

Primary DI
34250892980233
Brand
Spirometry PC Software
Company
CAREFUSION U.K. 232 LIMITED
Model
2.5
Catalog number
36-SPC1000-STK
Device description
Spirometry PC Software
Published
2017-10-27
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141936000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141936000MICROBLAB, MICROLOOPCarefusion Germany 234 GmbH2014-12-29BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34250892980233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3425089298023334250892980233

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary function analysis system, adultA device used to measure the function of the respiratory system in adults and compliant children. It usually includes a spirometer with volume-sensing (e.g., rolling-seal, bellow) and flow-sensing (e.g., pneumotachometer) devices, a gas analyser for evaluation of absolute lung volumes and gas-diffusing capacity of the lungs, and computer capabilities for data processing and recording; a total-body plethysmograph to measure both lung volumes and airway resistance may be included. The device is mostly used for outpatient or presurgical screening, and may also be used in the diagnosis and evaluation of common diseases in older children [e.g., asthma, cystic fibrosis (CF), chest deformities].

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
54250892980091Micro Medical36-ML3535 MK8-REGION 2&336-ML3535 MK8-REGION 2&32016-08-04
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
34250892980257Spirometry PC Software Licence2.536-SPC0105-STK2017-10-27
34250892980264Spirometry PC Software Update2.536-SPCU100-STK2017-10-27

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