PATHEN MEDICAL LLC

Address:271 Speciality Point,Sanford,FL,32771,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

Set, Administration, Intravascular (FPA) (10)

Premarket Exempt

Clear

FK20201E - 00850005864004 Catalog Number :

Device Description : 6” (15.25cm Standard bore extension set with pinch clamp male luer lock with non 6” (15.25cm Standard bore extension set with pinch clamp male luer lock with non-bonded needle-free connector )

Device Class : 2

Duns Number: 042928915

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

FK20220E - 00850005864059 Catalog Number :

Device Description : 18” (46cm) Standard bore extension set with roller clamp, 1 needleless connector 18” (46cm) Standard bore extension set with roller clamp, 1 needleless connector, male luer-lock and female luer

Device Class :

Duns Number: 042928915

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

FK20225E - 00850005864066 Catalog Number :

Device Class : 2

Duns Number: 042928915

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

FK30100G - 00850005864080 Catalog Number :

Device Description : 100" (254cm) Universal 20 drop, spike, roller clamp, slide clamp, male pin luer lock

Device Class : 2

Duns Number: 042928915

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

FK20245E - 00850005864097 Catalog Number :

Device Description : 32” Standard bore extension set with slide clamp, 2 needleless Y-site, male lu 32” Standard bore extension set with slide clamp, 2 needleless Y-site, male luer lock and female luer

Device Class : 2

Duns Number: 042928915

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

FK20200E - 00850005864127 Catalog Number :

Device Description : 6” (15.25cm Minibore/smallbore extension set with slide clamp, male luer lock wi 6” (15.25cm Minibore/smallbore extension set with slide clamp, male luer lock with non-bonded needle-free connector

Device Class : 2

Duns Number: 042928915

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

FK20203E - 00850005864134 Catalog Number :

Device Description : 6” (15.25cm) Microbore extension set with pinch clamp male luer lock with non-bo 6” (15.25cm) Microbore extension set with pinch clamp male luer lock with non-bonded needle-free connector, Purple slide clamp High Pressure (Sterile Packaging)

Device Class : 2

Duns Number: 042928915

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

FK20210E - 00850005864141 Catalog Number :

Device Description : 5” (13cm) Bi-fuse Minibore extension set with 3 slide clamps male luer lock and 5” (13cm) Bi-fuse Minibore extension set with 3 slide clamps male luer lock and 2 non-bonded needle-free connectors

Device Class : 2

Duns Number: 042928915

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

FK20211E - 00850005864158 Catalog Number :

Device Description : 5” (13cm) Bi-fuse Minibore extension set with 2 slide clamps male luer lock and 5” (13cm) Bi-fuse Minibore extension set with 2 slide clamps male luer lock and 2 bonded needle-free connectors

Device Class : 2

Duns Number: 042928915

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

FK20215E - 00850005864172 Catalog Number :

Device Description : 5” (13cm) Tri-fuse Minibore extension set with 3 slide clamps male luer lock and 5” (13cm) Tri-fuse Minibore extension set with 3 slide clamps male luer lock and 3 non-bonded needle-free connectors

Device Class : 2

Duns Number: 042928915

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

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