Medical Components, Inc.

Address:1499 DELP DRIVE,HARLEYSVILLE,PA,19438,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, hemodialysis, implanted (MSD) (6) CATHETER, HEMODIALYSIS, NON-IMPLANTED (MPB) (4)

Premarket Exempt

No Yes

Clear

Split Cath® III - 00884908001006 Catalog Number :

Device Description : 16F X 55CM Split Cath® III CATHETER ONLY (CUFF 50CM FROM TIP)

Device Class : 2

Duns Number: 038000253

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 1

SPLIT CATH® III - 00884908001013 Catalog Number :

Device Description : 16F X 24CM PRE-CURVED SPLIT CATH® III CATHETER ONLY (CUFF 19CM FROM TIP)

Device Class : 2

Duns Number: 038000253

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 1

Split Cath® III - 00884908001020 Catalog Number :

Device Description : 16F X 28CM PRE-CURVED Split Cath® III CATHETER ONLY (CUFF 23CM FROM TIP)

Device Class : 2

Duns Number: 038000253

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 1

SPLIT CATH® III - 00884908001037 Catalog Number :

Device Description : 16F X 32CM PRE-CURVED SPLIT CATH® III CATHETER ONLY (CUFF 27CM FROM TIP)

Device Class : 2

Duns Number: 038000253

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 1

SPLIT CATH® III - 00884908001044 Catalog Number :

Device Description : 16F X 36CM PRE-CURVED SPLIT CATH® III CATHETER ONLY (CUFF 31CM FROM TIP)

Device Class : 2

Duns Number: 038000253

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 1

400XL - 00884908001396 Catalog Number :

Device Description : 14F X 20CM DUO-FLOW® 400XL IJ (CATHETER ONLY)

Device Class : 2

Duns Number: 038000253

Premarket Exempt : No

Product Code : MPB

Prescription Use : Yes

Device Count : 1

400XL - 00884908001433 Catalog Number :

Device Description : 14F X 20CM 400XL STRAIGHT FULL SET

Device Class : 2

Duns Number: 038000253

Premarket Exempt : No

Product Code : MPB

Prescription Use : Yes

Device Count : 1

400XL - 00884908001464 Catalog Number :

Device Description : 14F X 15CM DUO-FLOW® 400XL IJ FULL SET

Device Class : 2

Duns Number: 038000253

Premarket Exempt : No

Product Code : MPB

Prescription Use : Yes

Device Count : 1

400XL - 00884908001471 Catalog Number :

Device Description : 14F X 20CM DUO-FLOW® 400XL IJ FULL SET

Device Class : 2

Duns Number: 038000253

Premarket Exempt : No

Product Code : MPB

Prescription Use : Yes

Device Count : 1

Hemo-Flow® - 00884908001495 Catalog Number :

Device Description : 14.5F X 24CM Hemo-Flow® CATHETER FULL SET (CUFF 19CM FROM TIP)

Device Class : 2

Duns Number: 038000253

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 1

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