MEDIPLUS LTD

Address:UNIT 7 THE GATEWAY CENTRE,HIGH WYCOMBE, BUCKS Buckinghamshire,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

CATHETER, SUPRAPUBIC (AND ACCESSORIES) (KOB) (6) DEVICE, CYSTOMETRIC, HYDRAULIC (FEN) (4)

Premarket Exempt

No Yes

Clear

Mediplus - 05055140701138 Catalog Number :

Device Description : Air filled micro balloon catheter, 6Fr.

Device Class : 2

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : Yes

Device Count : 1

Morpheus - 05055140701176 Catalog Number :

Device Description : Morpheus Pump Tube Set

Device Class : 2

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : Yes

Device Count : 1

S-Cath™ - 05055140701190 Catalog Number :

Device Description : S-Cath™ System - Silicone suprapubic Foley (open tip) catheter, with introduc S-Cath™ System - Silicone suprapubic Foley (open tip) catheter, with introducer set, 14Fr. 10cc, 42cm

Device Class : 2

Duns Number: 228480810

Premarket Exempt : No

Product Code : KOB

Prescription Use : Yes

Device Count : 1

S-Cath™ - 05055140701206 Catalog Number :

Device Description : S-Cath™ System - Silicone suprapubic Foley (open tip) catheter, with introduce S-Cath™ System - Silicone suprapubic Foley (open tip) catheter, with introducer set, 16Fr. 10cc, 42cm

Device Class : 2

Duns Number: 228480810

Premarket Exempt : No

Product Code : KOB

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140701213 Catalog Number :

Device Description : Silicone 2 way suprapubic Foley (open tip) catheter 14Fr

Device Class : 2

Duns Number: 228480810

Premarket Exempt : No

Product Code : KOB

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140701220 Catalog Number :

Device Description : Silicone 2 way suprapubic Foley (open tip) catheter 16Fr

Device Class : 2

Duns Number: 228480810

Premarket Exempt : No

Product Code : KOB

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140701237 Catalog Number :

Device Description : Pump tube set for urodynamics system - Lifetech

Device Class : 2

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140701299 Catalog Number :

Device Description : Extension set 150cm long

Device Class : 2

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : Yes

Device Count : 1

S-Cath™ - 05055140701336 Catalog Number :

Device Description : S-Cath™ System - Silicone suprapubic Foley catheter, with introducer set, 12Fr. S-Cath™ System - Silicone suprapubic Foley catheter, with introducer set, 12Fr. 10cc, 42cm

Device Class : 2

Duns Number: 228480810

Premarket Exempt : No

Product Code : KOB

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140701343 Catalog Number :

Device Description : Silicone 2 way Foley catheter, 12Fr, standard

Device Class : 2

Duns Number: 228480810

Premarket Exempt : No

Product Code : KOB

Prescription Use : Yes

Device Count : 1

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