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, intravascular, therapeutic, long-term greater than 30 days (LJS) (6) Catheter, intravascular, therapeutic, short-term less than 30 days (FOZ) (2) Midline catheter (PND) (2)

Premarket Exempt

No Yes

Clear

PowerPICC Provena - 00801741224393 Catalog Number : CK001048

Device Description : Catheter Placement Kit

Device Class : 2

Duns Number: 044611812

Premarket Exempt : No

Product Code : LJS

Prescription Use : Yes

Device Count : 1

PowerGlide Pro - 00801741224553 Catalog Number : PCK00011

Device Description : Catheter Replacement Kit

Device Class : 2

Duns Number: 044611812

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

PowerGlide Pro - 00801741224560 Catalog Number : PCK00012

Device Description : Catheter Placement Kit

Device Class : 2

Duns Number: 044611812

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

PowerPICC - 00801741224577 Catalog Number : CK001049

Device Description : Catheter Placement Kit

Device Class : 2

Duns Number: 044611812

Premarket Exempt : No

Product Code : LJS

Prescription Use : Yes

Device Count : 1

PowerPICC Provena - 00801741224584 Catalog Number : CK001050

Device Description : Catheter Placement Kit

Device Class : 2

Duns Number: 044611812

Premarket Exempt : No

Product Code : LJS

Prescription Use : Yes

Device Count : 1

Sherlock 3CG+ TCS SR Halcyon SW Version 3.1.0 - 00801741224676 Catalog Number : S3CG+ TCS SR Halcyon SW v3.1.0

Device Description : CVAD Tip Confirmation System

Device Class : 2

Duns Number: 044611812

Premarket Exempt : No

Product Code : LJS

Prescription Use : Yes

Device Count : 1

Provena Midline - 00801741225130 Catalog Number : CK001054

Device Description : Catheter Placement Kit

Device Class : 2

Duns Number: 044611812

Premarket Exempt : No

Product Code : PND

Prescription Use : Yes

Device Count : 1

PowerPICC SOLO - 00801741225147 Catalog Number : CK001055

Device Description : Catheter Placement Kit

Device Class : 2

Duns Number: 044611812

Premarket Exempt : No

Product Code : LJS

Prescription Use : Yes

Device Count : 1

PowerPICC - 00801741225154 Catalog Number : CK001056

Device Description : Catheter Placement Kit

Device Class : 2

Duns Number: 044611812

Premarket Exempt : No

Product Code : LJS

Prescription Use : Yes

Device Count : 1

Provena Midline - 00801741225161 Catalog Number : CK001057

Device Description : Catheter Placement Kit

Device Class : 2

Duns Number: 044611812

Premarket Exempt : No

Product Code : PND

Prescription Use : Yes

Device Count : 1

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