FDA.reportPublic FDA data

Micro Medical

Primary DI
34250892980202
Brand
Micro Medical
Company
CAREFUSION U.K. 232 LIMITED
Model
36-SST1250
Catalog number
36-SST1250
Device description
Adult Mouthpieces one way
Published
2017-04-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYPMouthpiece, Breathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYPMouthpiece, BreathingAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34250892980202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3425089298020234250892980202

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.

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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
34250892980196Micro Medical36-SST100036-SST10002017-04-06
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
34250892980264Spirometry PC Software Update2.536-SPCU100-STK2017-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
20197344011312HUDSON 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
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