Laborie Medical Technologies Canada ULC

Address:180 International Drive,Portsmouth,NH,03801,US

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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) (10)

Premarket Exempt

No Yes

Clear

Two Catheter Set 10F and 4F - 00627825000390 Catalog Number :

Device Class :

Duns Number: 203383526

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : No

Device Count : 1

Dual Infusion Pump Tube Set - 00627825000420 Catalog Number :

Device Class : 2

Duns Number: 203383526

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : No

Device Count : 1

Infusion Pump Tube Set with Dampening Chamber - 00627825000437 Catalog Number :

Device Class : 2

Duns Number: 203383526

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : No

Device Count : 1

Dual Infusion Pump Tube Set - 00627825000444 Catalog Number :

Device Class : 2

Duns Number: 203383526

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : No

Device Count : 1

Infusion Pump Tube Set with Dampening Chamber - 00627825000451 Catalog Number :

Device Class : 2

Duns Number: 203383526

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : No

Device Count : 1

All Purpose Infusion Set - 00627825000468 Catalog Number :

Device Class : 2

Duns Number: 203383526

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : No

Device Count : 1

All Purpose Tubing Set - 00627825000475 Catalog Number :

Device Class : 2

Duns Number: 203383526

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : No

Device Count : 1

Dampening Chamber with Infusion Restrictor Tube - 00627825000482 Catalog Number :

Device Class : 2

Duns Number: 203383526

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : No

Device Count : 1

Wire Electrode Needle Set Female - 00627825000499 Catalog Number :

Device Class : 2

Duns Number: 203383526

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : No

Device Count : 1

Wire Electrode Needle Set Male - 00627825000505 Catalog Number :

Device Class : 2

Duns Number: 203383526

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : No

Device Count : 1

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