PATHEN MEDICAL LLC

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

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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, Intravascular, Therapeutic, Short-Term Less Than 30 Days (FOZ) (5) Set, Administration, Intravascular (FPA) (5)

Premarket Exempt

Clear

FK20251E - 00850005864189 Catalog Number :

Device Description : 18” (46cm) Standard bore extension set with 0.22 Micron Filter pinch clamp, male 18” (46cm) Standard bore extension set with 0.22 Micron Filter pinch clamp, male lure-lock and female luer

Device Class : 2

Duns Number: 042928915

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

FK20255E - 00850005864196 Catalog Number :

Device Description : 18” (46cm) Standard bore extension set with 1.2 Micron Filter, pinch clamp, male 18” (46cm) Standard bore extension set with 1.2 Micron Filter, pinch clamp, male lure-lock and female luer

Device Class : 2

Duns Number: 042928915

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

FK30106G - 00850005864202 Catalog Number :

Device Description : 106" (269cm) Universal 20 drop spike, back check valve (BCV), 2 needle-free Y-si 106" (269cm) Universal 20 drop spike, back check valve (BCV), 2 needle-free Y-sites 90" and 10" above distal end, slide clamp, roller clamp, male spin luer lock

Device Class : 2

Duns Number: 042928915

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

FK50030S - 00850005864219 Catalog Number :

Device Description : 30” Minibore extension set with slide clamp, male luer-lock and female luer

Device Class : 2

Duns Number: 042928915

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

FK50060S - 00850005864226 Catalog Number :

Device Description : 60” Minibore extension set with slide clamp, male luer-lock and female luer

Device Class : 2

Duns Number: 042928915

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

PR-84214 - 00850005864233 Catalog Number :

Device Description : 14g x 1 1/4” IV CATHETER PURSAFETY R

Device Class : 2

Duns Number: 042928915

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

PR-84216 - 00850005864240 Catalog Number :

Device Description : 16g x 1 1/4” IV CATHETER PURSAFETY R

Device Class : 2

Duns Number: 042928915

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

PR-84218 - 00850005864257 Catalog Number :

Device Description : 18g x 1 1/4” IV CATHETER PURSAFETY R

Device Class : 2

Duns Number: 042928915

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

PR-84220 - 00850005864264 Catalog Number :

Device Description : 20g x 1 1/4” IV CATHETER PURSAFETY R

Device Class : 2

Duns Number: 042928915

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

PR-842202 - 00850005864271 Catalog Number :

Device Description : 20g x 1” IV CATHETER PURSAFETY R

Device Class : 2

Duns Number: 042928915

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

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