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) (5) ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE (CCK) (4) MONITOR, ESOPHAGEAL MOTILITY, AND TUBE (KLA) (1)

Premarket Exempt

No Yes

Clear

Mediplus - 05055140703279 Catalog Number :

Device Description : Twin Extension set, 150cm long

Device Class : 2

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : Yes

Device Count : 1

TIMM - 05055140703392 Catalog Number :

Device Description : Gas tubing kit

Device Class : 2

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : Yes

Device Count : 1

TIMM - 05055140703415 Catalog Number :

Device Description : Water pump tubing kit

Device Class : 2

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : Yes

Device Count : 1

TIMM - 05055140703422 Catalog Number :

Device Description : Long water tubing kit

Device Class : 2

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : Yes

Device Count : 1

TIMM - 05055140703439 Catalog Number :

Device Description : Short water tubing kit

Device Class : 2

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140703842 Catalog Number :

Device Description : Capnomask™ Paediatric Oxygen mask + CO2 sampling line 300cm with male/female con Capnomask™ Paediatric Oxygen mask + CO2 sampling line 300cm with male/female connector + O2 tube 200cm

Device Class : 2

Duns Number: 228480810

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140703859 Catalog Number :

Device Description : Capnomask™ Ophthalmic oxygen mask + CO2 sampling line 300cm with male/female con Capnomask™ Ophthalmic oxygen mask + CO2 sampling line 300cm with male/female connector + O2 tube 200cm

Device Class : 2

Duns Number: 228480810

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Prometheus - 05055140703866 Catalog Number :

Device Description : Pathway Anorectal response catheter, 14Fr

Device Class : 2

Duns Number: 228480810

Premarket Exempt : No

Product Code : KLA

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140703880 Catalog Number :

Device Description : Capnomask™ DISS Connector Ophthalmic oxygen mask + CO2 sampling line 300cm with Capnomask™ DISS Connector Ophthalmic oxygen mask + CO2 sampling line 300cm with male/male connector + O2 tube 200cm

Device Class : 2

Duns Number: 228480810

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140703897 Catalog Number :

Device Description : Capnomask™ DISS Connector Adult Oxygen mask + CO2 sampling line 300cm with male/ Capnomask™ DISS Connector Adult Oxygen mask + CO2 sampling line 300cm with male/female connector + O2 tube 200cm

Device Class : 2

Duns Number: 228480810

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

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