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) (7) Mask, Oxygen (BYG) (3)

Premarket Exempt

No Yes

Clear

Infant Resuscitation Kit. T-Piece Circuit - 00854401006440 Catalog Number :

Device Description : 1.8m (70") with Anatomical 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 - 00854401006457 Catalog Number :

Device Description : 1.8m (70") Oxygen Line 2.1m (82") Anatomical Masks 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 - 00854401006488 Catalog Number :

Device Description : 1.8m (70") Oxygen Line 2.1m (82") Anatomical Mask Size 0

Device Class : 2

Duns Number: 504406273

Premarket Exempt : No

Product Code : BYE

Prescription Use : No

Device Count : 1

Infant Resuscitation Kit T-Piece Circuit - 00854401006501 Catalog Number :

Device Description : 1.8m (70") Oxygen Line 2.1m (82") Anatomical Mask Size 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 - 00854401006525 Catalog Number :

Device Description : 1.8m (70") with Anatomical Mask Size 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 - 00854401006549 Catalog Number :

Device Description : 1.8m (70") Oxygen Line 2.1m (82") and Round Masks Size 0

Device Class : 2

Duns Number: 504406273

Premarket Exempt : No

Product Code : BYE

Prescription Use : No

Device Count : 1

Infant Resuscitation Kit. T-Piece Circuit - 00854401006563 Catalog Number :

Device Description : 1.8m (70") Oxygen Line 2.1m (82") and Round Masks Size 1

Device Class : 2

Duns Number: 504406273

Premarket Exempt : No

Product Code : BYE

Prescription Use : No

Device Count : 1

Resuscitation Face Mask Single Use Round Silicone Neonatal Size 0 - 00854401006570 Catalog Number :

Device Class : 1

Duns Number: 504406273

Premarket Exempt : Yes

Product Code : BYG

Prescription Use : Yes

Device Count : 1

Resuscitation Face Mask Single Use Round Silicone Infant Size 1 - 00854401006587 Catalog Number :

Device Class : 1

Duns Number: 504406273

Premarket Exempt : Yes

Product Code : BYG

Prescription Use : Yes

Device Count : 1

Resuscitation Face Mask Single Use Anatomical with Pre-Inflated Cushion Neonatal - 00854401006600 Catalog Number :

Device Class : 1

Duns Number: 504406273

Premarket Exempt : Yes

Product Code : BYG

Prescription Use : Yes

Device Count : 1

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