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

DEVICE, CYSTOMETRIC, HYDRAULIC (FEN) (6) ACCESSORIES, CATHETER (KGZ) (2) CATHETER, SUPRAPUBIC (AND ACCESSORIES) (KOB) (2)

Premarket Exempt

No Yes

Clear

Mediplus - 05055140702203 Catalog Number :

Device Description : Double lumen cystometery catheter, 8f, Standard

Device Class : 1

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140702210 Catalog Number :

Device Description : Double lumen cystometry catheter, 6 Fr. Standard

Device Class : 1

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 1

S-Cath™ - 05055140702234 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, 12Fr. 10cc, 42cm

Device Class : 2

Duns Number: 228480810

Premarket Exempt : No

Product Code : KOB

Prescription Use : Yes

Device Count : 1

S-Cath™ - 05055140702265 Catalog Number :

Device Description : S-Cath™ System - Silicone suprapubic Foley catheter, with introducer set, 14Fr S-Cath™ System - Silicone suprapubic Foley 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

Mediplus - 05055140702272 Catalog Number :

Device Description : Pump tube set for urodynamics system - Lectromed/SIEM

Device Class : 2

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140702296 Catalog Number :

Device Description : Pump tube set for urodynamics system - Laborie

Device Class : 2

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140702319 Catalog Number :

Device Description : Pump tube set for urodynamics system - Neomedix

Device Class : 2

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140702326 Catalog Number :

Device Description : Pump tube set for urodynamics system - MMS UD2000

Device Class : 2

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140702333 Catalog Number :

Device Description : Pump tube set for MMS Libra, Libraplus & Solar

Device Class : 2

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140702364 Catalog Number :

Device Description : Pump tube set for Sedia urodynamics system

Device Class : 2

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : Yes

Device Count : 1

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