FDA.reportPublic FDA data

Micro Medical

Primary DI
54250892980138
Brand
Micro Medical
Company
CAREFUSION U.K. 232 LIMITED
Model
36-RPM01-STK
Catalog number
36-RPM01-STK
Device description
MicroRPM
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
CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54250892980138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5425089298013854250892980138

GMDN Terms#

Term, Definition table
TermDefinition
Airway pressure monitor, poweredA mains electricity (AC-powered) device designed to continuously measure and display the pressure values, positive and/or negative, in the upper airway (e.g., the maximal averaged inspiratory and expiratory static mouth pressure, and/or negative pressure generated by the patient during inspiration), typically in the assessment of patients with compromised pulmonary function and to determine the appropriateness of discontinuing mechanical ventilation. It typically includes a pressure indicator and a built-in alarm to signal pressure levels that exceed specific limits. It may contain batteries for independent operation when line-power is not available.

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
34250892980233Spirometry PC Software2.536-SPC1000-STK2017-10-27
34250892980257Spirometry PC Software Licence2.536-SPC0105-STK2017-10-27

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00851232007158OxyPAP PAP DEVICE w/ 22mm MASK ADAPTOR w/o MANOMETERD R BURTON HEALTHCARE, LLCCAP2026-04-28
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyCAP2026-04-15
04710810114380N/AGALEMED CORPORATIONCAP2026-03-05
04710810114427N/AGALEMED CORPORATIONCAP2026-03-05
04710810117008N/AGALEMED CORPORATIONCAP2026-03-05
44710810114388N/AGALEMED CORPORATIONCAP2026-03-05
44710810114425N/AGALEMED CORPORATIONCAP2026-03-05
44710810117006N/AGALEMED CORPORATIONCAP2026-03-05
07045432116151The BAG ManometerLaerdal Medical ASCAP2026-01-14
07045432116144The BAG ManometerLaerdal Medical ASCAP2026-01-14
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14250892907274JaegerJaeger Medical GmbHCAP2025-11-24
14250892907281JaegerJaeger Medical GmbHCAP2025-11-24
14250892907946JaegerJaeger Medical GmbHCAP2025-07-29
14250892908004JaegerJaeger Medical GmbHCAP2025-07-29
14250892908011JaegerJaeger Medical GmbHCAP2025-07-29
14250892908028JaegerJaeger Medical GmbHCAP2025-07-29
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10889483587508AirLife™AIRLIFECAP2025-03-13
10889483587515AirLife™AIRLIFECAP2025-03-13
30889483587502AirLife™Sunmed Group Holdings, LLCCAP2025-03-13
30889483587519AirLife™Sunmed Group Holdings, LLCCAP2025-03-13
05055931102328FlexicareFLEXICARE MEDICAL LIMITEDCAP2024-03-05
05707480148882Ambu® Disposable Pressure ManometerAmbu A/SCAP2024-01-12
05707480148905Ambu® Disposable Pressure ManometerAmbu A/SCAP2024-01-12