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

Attachment, Breathing, Positive End Expiratory Pressure (BYE) (5) Incubator, Neonatal Transport (FPL) (2) Ventilator, Emergency, Manual (Resuscitator) (BTM) (2) Tubing, Noninvasive (GAZ) (1)

Premarket Exempt

No Yes

Clear

Disposable Skin Temperature Probes - 00854401006310 Catalog Number :

Device Class : 2

Duns Number: 504406273

Premarket Exempt : No

Product Code : FPL

Prescription Use : No

Device Count : 1

Reusable Skin Temperature Probes - 00854401006327 Catalog Number :

Device Class : 2

Duns Number: 504406273

Premarket Exempt : No

Product Code : FPL

Prescription Use : No

Device Count : 1

Suction Tubing 0.5m (18") - 00854401006341 Catalog Number :

Device Class : 2

Duns Number: 504406273

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : No

Device Count : 1

Infant Resuscitator T-Piece Catheter Access Adapter - 00854401006365 Catalog Number :

Device Class : 2

Duns Number: 504406273

Premarket Exempt : No

Product Code : BYE

Prescription Use : No

Device Count : 1

Infant Resuscitation Kit. T-Piece Circuit - 00854401006372 Catalog Number :

Device Description : 1.8m (70") Oxygen Line 2.1m (82") Catheter Access Adapter

Device Class : 2

Duns Number: 504406273

Premarket Exempt : No

Product Code : BYE

Prescription Use : No

Device Count : 1

NeoPIP Infant Resuscitator - 00854401006389 Catalog Number :

Device Class : 2

Duns Number: 504406273

Premarket Exempt : No

Product Code : BTM

Prescription Use : No

Device Count : 1

NeoPIP Infant Resuscitator Universal Mounting Bracket - 00854401006396 Catalog Number :

Device Class : 2

Duns Number: 504406273

Premarket Exempt : No

Product Code : BTM

Prescription Use : No

Device Count : 1

Infant Resuscitator T-Piece Circuit with Adjustable PEEP - 00854401006402 Catalog Number :

Device Class : 2

Duns Number: 504406273

Premarket Exempt : No

Product Code : BYE

Prescription Use : No

Device Count : 1

Infant Resuscitation Kit. T-Piece Circuit - 00854401006426 Catalog Number :

Device Description : 1.8m (70") with Round Masks Sizes 0 + 1

Device Class : 2

Duns Number: 504406273

Premarket Exempt : No

Product Code : BYE

Prescription Use : No

Device Count : 1

Infant Resuscitation Kit. T-Piece Circuit - 00854401006433 Catalog Number :

Device Description : 1.8m (70") Oxygen Line 2.1m (82") Round Masks Sizes 0 + 1

Device Class : 2

Duns Number: 504406273

Premarket Exempt : No

Product Code : BYE

Prescription Use : No

Device Count : 1

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