Bard Access Systems, Inc.

Address:605 North 5600 West,Salt Lake City,UT,84116,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, IRRIGATION (GBX) (1) Catheter,intravascular,therapeutic,long-term greater than 30 days (LJS) (1) PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR (LJT) (1) TUBES, GASTROINTESTINAL (AND ACCESSORIES) (KNT) (1)

Premarket Exempt

No Yes

Clear

Navarre - 00801741000348 Catalog Number : NNU6LPT

Device Description : Navarre Universal Drainage Catheter with Nitinol, Locking Pigtail, 6 Fr x 30 cm

Device Class : 1

Duns Number: 044611812

Premarket Exempt : Yes

Product Code : GBX

Prescription Use : Yes

Device Count : 1

PowerPICC® Catheter - 00801741000423 Catalog Number : 3275108

Device Description : DOT 5 Fr DL PowerPICC

Device Class : 2

Duns Number: 044611812

Premarket Exempt : No

Product Code : LJS

Prescription Use : Yes

Device Count : 1

PowerPort M.R.I. Implantable Port - 00801741000430 Catalog Number : 1808000

Device Description : PowerPort M.R.I. Implantable Port with Attachable 8F ChronoFlex Open-Ended Singl PowerPort M.R.I. Implantable Port with Attachable 8F ChronoFlex Open-Ended Single-Lumen Venous Catheter Intermediate Kit (with Suture Plugs)

Device Class : 2

Duns Number: 044611812

Premarket Exempt : No

Product Code : LJT

Prescription Use : Yes

Device Count : 1

HemoSplit Long-Term Hemodialysis Catheter - 00801741000454 Catalog Number : 5733730

Device Description : HEMOSPLIT HEMODIALYSIS CATH, ST, AIRGUARD, 14.5 FR. 23cm

Device Class : 2

Duns Number: 044611812

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 1

Bard Delux Guidewire PEG System - 00801741000478 Catalog Number : 000793

Device Description : Guidewire PEG System

Device Class :

Duns Number: 044611812

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

VACCESS LT LONG-TERM HEMODIALYSIS CATHETER - 00801741010644 Catalog Number : 5103150

Device Description : VACCESS ST, 14.5 FR. 15cm

Device Class : 2

Duns Number: 044611812

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 1

VACCESS LT LONG-TERM HEMODIALYSIS CATHETER - 00801741010651 Catalog Number : 5103190

Device Description : VACCESS ST, 14.5 FR. 19cm

Device Class : 2

Duns Number: 044611812

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 1

VACCESS LT LONG-TERM HEMODIALYSIS CATHETER - 00801741010668 Catalog Number : 5103230

Device Description : VACCESS ST, 14.5 FR. 23cm

Device Class : 2

Duns Number: 044611812

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 1

VACCESS LT LONG-TERM HEMODIALYSIS CATHETER - 00801741010675 Catalog Number : 5103270

Device Description : VACCESS ST, 14.5 FR. 27cm

Device Class : 2

Duns Number: 044611812

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 1

VACCESS LT LONG-TERM HEMODIALYSIS CATHETER - 00801741010682 Catalog Number : 5103310

Device Description : VACCESS ST, 14.5 FR. 31cm

Device Class : 2

Duns Number: 044611812

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 1

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