FLEXICARE MEDICAL LIMITED

Address:CYNON VALLEY BUSINESS PARK,RHONDDA CYNON TAFF Wales,GB

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Humidifier, Respiratory Gas, (Direct Patient Interface) (BTT) (4) Airway, Oropharyngeal, Anesthesiology (CAE) (2) Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (CCK) (2) Cannula, Nasal, Oxygen (CAT) (2) Condenser, Heat And Moisture (Artificial Nose) (BYD) (1) Nebulizer (Direct Patient Interface) (CAF) (1)

Premarket Exempt

No Yes

Clear

HME-Booster T-piece WFL + Hygrovent S HMEF - 05055788792345 Catalog Number :

Device Class : 2

Duns Number: 504406273

Premarket Exempt : No

Product Code : BTT

Prescription Use : No

Device Count : 1

HME-Booster T-piece WFL Comfort + Hygrovent S HMEF - 05055788792352 Catalog Number :

Device Class : 2

Duns Number: 504406273

Premarket Exempt : No

Product Code : BTT

Prescription Use : No

Device Count : 1

Climavent XS Angled HME Extra Small - 05055788792369 Catalog Number :

Device Class : 1

Duns Number: 504406273

Premarket Exempt : Yes

Product Code : BYD

Prescription Use : Yes

Device Count : 1

Hygrovent Gold Basic WFL - 05055788792376 Catalog Number :

Device Class : 2

Duns Number: 504406273

Premarket Exempt : No

Product Code : BTT

Prescription Use : No

Device Count : 1

Laryseal Clear Laryngeal Mask Airway Slimline Pack Size 1 - 05055788793700 Catalog Number :

Device Class : 1

Duns Number: 504406273

Premarket Exempt : Yes

Product Code : CAE

Prescription Use : Yes

Device Count : 1

Laryseal Clear Laryngeal Mask Airway Slimline Pack Size 1.5 - 05055788793717 Catalog Number :

Device Class : 1

Duns Number: 504406273

Premarket Exempt : Yes

Product Code : CAE

Prescription Use : Yes

Device Count : 1

Hygrovent Gold Comfort - 05055788793786 Catalog Number :

Device Class : 2

Duns Number: 504406273

Premarket Exempt : Yes

Product Code : BTT

Prescription Use : Yes

Device Count : 1

Dual Adult Nasal Cannula 7ft O2 Delivery/CO2 Monitoring, Filter, Microstream Lue - 05055931101048 Catalog Number :

Device Description : Dual Adult Nasal Cannula 7ft O2 Delivery/CO2 Monitoring, Filter, Microstream Lue Dual Adult Nasal Cannula 7ft O2 Delivery/CO2 Monitoring, Filter, Microstream Luer, M-M Adapter

Device Class : 1

Duns Number: 504406273

Premarket Exempt : No

Product Code : CCK, CAT

Prescription Use : No

Device Count : 1

Dual Pediatric Nasal Cannula 14ft O2 Delivery/CO2 Monitoring, Filter, Microstrea - 05055931101079 Catalog Number :

Device Description : Dual Pediatric Nasal Cannula 14ft O2 Delivery/CO2 Monitoring, Filter, Microstrea Dual Pediatric Nasal Cannula 14ft O2 Delivery/CO2 Monitoring, Filter, Microstream Luer, M-M

Device Class : 1

Duns Number: 504406273

Premarket Exempt : No

Product Code : CCK, CAT

Prescription Use : No

Device Count : 1

Maxineb Duo Filter Pad - 05055931101963 Catalog Number :

Device Class : 2

Duns Number: 504406273

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

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