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

PMG0100 - 00850005864486 Catalog Number :

Device Description : 100” 60 drop, vented/non-vented drip chamber, roller clamp, pre-slit Y-site, nee 100” 60 drop, vented/non-vented drip chamber, roller clamp, pre-slit Y-site, needleless Y-site connector, ROTATING MALE LUER

Device Class : 2

Duns Number: 042928915

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

PMG0083 - 00850005864493 Catalog Number :

Device Description : 83” 15 drop, non-vented drip chamber, roller clamp, pre-slit Y-site, needleless 83” 15 drop, non-vented drip chamber, roller clamp, pre-slit Y-site, needleless Y-site connector, ROTATING MALE LUER

Device Class : 2

Duns Number: 042928915

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

PMG0083 - 00850005864509 Catalog Number :

Device Description : 84” 10 drop, vented/non-vented drip chamber, roller clamp, pre-slit Y-site, need 84” 10 drop, vented/non-vented drip chamber, roller clamp, pre-slit Y-site, needleless Y-site connector,

Device Class : 2

Duns Number: 042928915

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

BA-1507-13 - 00850005864516 Catalog Number :

Device Description : Administration set W/Spike, 150 Micron filter w/Y port, stop Cock, 30ml Syringe, Administration set W/Spike, 150 Micron filter w/Y port, stop Cock, 30ml Syringe, 60" Smal bore tubing. (25 per box)

Device Class :

Duns Number: 042928915

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

BASN-60-150 - 00850005864523 Catalog Number :

Device Description : Administration set W/Spike, 150 Micron Filter & 60 ml Syringe

Device Class :

Duns Number: 042928915

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

PM007 - 00850005864530 Catalog Number :

Device Description : 7" Macro Bore, extenstion set with pinch clamp

Device Class : 2

Duns Number: 042928915

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

PME014B - 00850005864547 Catalog Number :

Device Description : 14" Microbore extenstion set with bonded needle-free connector

Device Class :

Duns Number: 042928915

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

CODAN - 00850005864554 Catalog Number :

Device Description : 7" High Pressure Extension Set with T connector

Device Class :

Duns Number: 042928915

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

BASNWS -30/150 - 00850005864561 Catalog Number :

Device Description : Administration Set, NO Spike, 150 Micron Filter, 30cc Syringe

Device Class :

Duns Number: 042928915

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

BM-2135.17 - 00850005864578 Catalog Number :

Device Description : Adminstration Set, Female Luer Lock, 150 Micron Filter w/ Male Luer Lock

Device Class : 2

Duns Number: 042928915

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

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