Phase One Medical LLC

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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, Hemodialysis, Implanted (MSD) (10)

Premarket Exempt

Clear

Symetrex - M967R20019 Catalog Number : R20019

Device Description : Long-term Hemodialysis/Apheresis Catheter, Exchange Kit, 15.5 Fr x 19 cm

Device Class : 2

Duns Number: 131502671

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 1

Symetrex - M967R20023 Catalog Number : R20023

Device Description : Long-term Hemodialysis/Apheresis Catheter, Exchange Kit, 15.5 Fr x 23 cm

Device Class : 2

Duns Number: 131502671

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 1

Symetrex - M967R20028 Catalog Number : R20028

Device Description : Long-term Hemodialysis/Apheresis Catheter, Exchange Kit, 15.5 Fr x 28 cm

Device Class : 2

Duns Number: 131502671

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 1

Symetrex - M967R20033 Catalog Number : R20033

Device Description : Long-term Hemodialysis/Apheresis Catheter, Exchange Kit, 15.5 Fr x 33 cm

Device Class : 2

Duns Number: 131502671

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 1

Symetrex - M967S20019 Catalog Number : S20019

Device Description : Long-term Hemodialysis/Apheresis Catheter, Standard Kit, 15.5 Fr x 19 cm

Device Class : 2

Duns Number: 131502671

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 1

Symetrex - M967S20023 Catalog Number : S20023

Device Description : Long-term Hemodialysis/Apheresis Catheter, Standard Kit, 15.5 Fr x 23 cm

Device Class : 2

Duns Number: 131502671

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 1

Symetrex - M967S20028 Catalog Number : S20028

Device Description : Long-term Hemodialysis/Apheresis Catheter, Standard Kit, 15.5 Fr x 28 cm

Device Class : 2

Duns Number: 131502671

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 1

Symetrex - M967S20033 Catalog Number : S20033

Device Description : Long-term Hemodialysis/Apheresis Catheter, Standard Kit, 15.5 Fr x 33 cm

Device Class : 2

Duns Number: 131502671

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 1

Symetrex - M967S20037 Catalog Number : S20037

Device Description : Long-term Hemodialysis/Apheresis Catheter, Standard Kit, 15.5 Fr x 37 cm

Device Class : 2

Duns Number: 131502671

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 1

Symetrex - M967S20042 Catalog Number : S20042

Device Description : Long-term Hemodialysis/Apheresis Catheter, Standard Kit, 15.5 Fr x 42 cm

Device Class : 2

Duns Number: 131502671

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 1

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