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) (7) Condenser, Heat And Moisture (Artificial Nose) (BYD) (3)

Premarket Exempt

No Yes

Clear

Climatrach Tracheostomy HME with Oxygen Port - 05055788792246 Catalog Number :

Device Class : 1

Duns Number: 504406273

Premarket Exempt : Yes

Product Code : BYD

Prescription Use : Yes

Device Count : 1

Climatrach Tracheostomy HME with Safety Valve - 05055788792253 Catalog Number :

Device Class : 1

Duns Number: 504406273

Premarket Exempt : Yes

Product Code : BYD

Prescription Use : Yes

Device Count : 1

Climatrach Tracheostomy HME + Oxygen Port + Safety Valve - 05055788792260 Catalog Number :

Device Class : 1

Duns Number: 504406273

Premarket Exempt : Yes

Product Code : BYD

Prescription Use : Yes

Device Count : 1

HME-Booster T-Piece - 05055788792277 Catalog Number :

Device Class : 2

Duns Number: 504406273

Premarket Exempt : No

Product Code : BTT

Prescription Use : No

Device Count : 1

Hygrovent Gold Basic - 05055788792284 Catalog Number :

Device Class : 2

Duns Number: 504406273

Premarket Exempt : No

Product Code : BTT

Prescription Use : No

Device Count : 1

Hygrovent Gold Comfort - 05055788792291 Catalog Number :

Device Class : 2

Duns Number: 504406273

Premarket Exempt : No

Product Code : BTT

Prescription Use : No

Device Count : 1

Hygrovent Gold Standard - 05055788792307 Catalog Number :

Device Class : 2

Duns Number: 504406273

Premarket Exempt : No

Product Code : BTT

Prescription Use : No

Device Count : 1

HME-Booster T-Piece with WFL - 05055788792314 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 Kit 7 with 3 X HMEF and Catheter Mount - 05055788792321 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 Kit 6 with 3 X HMEF - 05055788792338 Catalog Number :

Device Class : 2

Duns Number: 504406273

Premarket Exempt : No

Product Code : BTT

Prescription Use : No

Device Count : 1

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