NIPRO MEDICAL CORPORATION

Address:3150 NW 107TH AVE,Doral,FL,33172,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

Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days (FOZ) (8) Catheter, Angioplasty, Peripheral, Transluminal (LIT) (2)

Premarket Exempt

Clear

Cronus HP PTA Balloon Catheter - 00383790009577 Catalog Number :

Device Description : OTW High Pressure Peripheral Balloon Catheter

Device Class : 2

Duns Number: 797372554

Premarket Exempt : No

Product Code : LIT

Prescription Use : Yes

Device Count : 1

Cronus HP PTA Balloon Catheter - 00383790009591 Catalog Number :

Device Description : OTW High Pressure Peripheral Balloon Catheter

Device Class : 2

Duns Number: 797372554

Premarket Exempt : No

Product Code : LIT

Prescription Use : Yes

Device Count : 1

NIPRO SAFETOUCH IV CATHETER - 00383790009614 Catalog Number :

Device Description : 16G x 2”, Winged, 180 ml/min

Device Class : 2

Duns Number: 797372554

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

NIPRO SAFETOUCH IV CATHETER - 00383790009621 Catalog Number :

Device Description : 18G x 1 1/4”, Winged, 90 ml/min

Device Class : 2

Duns Number: 797372554

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

NIPRO SAFETOUCH IV CATHETER - 00383790009638 Catalog Number :

Device Description : 18G x 2”, Winged, 90 ml/min

Device Class : 2

Duns Number: 797372554

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

NIPRO SAFETOUCH IV CATHETER - 00383790009645 Catalog Number :

Device Description : 20G x 1 1/4”, Winged, 54 ml/min

Device Class : 2

Duns Number: 797372554

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

NIPRO SAFETOUCH IV CATHETER - 00383790009652 Catalog Number :

Device Description : 20G x 2”, Winged, 54 ml/min

Device Class : 2

Duns Number: 797372554

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

NIPRO SAFETOUCH IV CATHETER - 00383790009669 Catalog Number :

Device Description : 22G x 1”, Winged, 36 ml/min

Device Class : 2

Duns Number: 797372554

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

NIPRO SAFETOUCH IV CATHETER - 00383790009676 Catalog Number :

Device Description : 22G x 1 1/4”, Winged, 36 ml/min

Device Class : 2

Duns Number: 797372554

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

NIPRO SAFETOUCH IV CATHETER - 00383790009683 Catalog Number :

Device Description : 24G x 3/4”, Winged, 21 ml/min

Device Class : 2

Duns Number: 797372554

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

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