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) (3) INTRODUCER, CATHETER (DYB) (3) Midline catheter (PND) (1) System, image processing, radiological (LLZ) (1) System, imaging, pulsed echo, ultrasonic (IYO) (1) Catheter, hemodialysis, implanted (MSD) (1) Transducer, ultrasonic, diagnostic (ITX) (1) Catheter,intravascular,therapeutic,long-term greater than 30 days (LJS) (1)

Premarket Exempt

No Yes

Clear

Provena Midline - 00801741225178 Catalog Number : CK001058

Device Description : Catheter Placement Kit

Device Class : 2

Duns Number: 044611812

Premarket Exempt : No

Product Code : PND

Prescription Use : Yes

Device Count : 1

PowerPICC - 00801741225802 Catalog Number : CK000854B

Device Description : Catheter Placement Kit

Device Class : 2

Duns Number: 044611812

Premarket Exempt : No

Product Code : LJS

Prescription Use : Yes

Device Count : 1

PowerPICC - 00801741225819 Catalog Number : CK000652B

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 - 00801741225826 Catalog Number : CK000653B

Device Description : Catheter Placement Kit

Device Class : 2

Duns Number: 044611812

Premarket Exempt : No

Product Code : LJS

Prescription Use : Yes

Device Count : 1

Site~Rite 8 Ultrasound System - 00801741225895 Catalog Number : SR8v3.0.1

Device Description : Site~Rite 8 Software v. 3.0.1

Device Class : 2

Duns Number: 044611812

Premarket Exempt : No

Product Code : LLZ, IYO, ITX

Prescription Use : Yes

Device Count : 1

Sherlock - 10801741036078 Catalog Number : 9770009

Device Description : TLS II Sensor Holder 10PK, Non-Sterile

Device Class :

Duns Number: 044611812

Premarket Exempt : No

Product Code : LJS

Prescription Use : No

Device Count : 10

Clamps - 10801741074490 Catalog Number : 0601870

Device Description : 259 CLAMPS-N/S 3/PKG

Device Class :

Duns Number: 044611812

Premarket Exempt : No

Product Code : MSD

Prescription Use : Yes

Device Count : 3

Introducer Needle - 10801741075336 Catalog Number : S03118-275

Device Description : SecLoc,INTRO 18Gx2.75

Device Class :

Duns Number: 044611812

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 500

Introducer Needle - 10801741075343 Catalog Number : S03118-275W

Device Description : SecureLoc 18G x 2.75 inch

Device Class :

Duns Number: 044611812

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 500

Introducer Needle - 10801741075381 Catalog Number : S03121-275

Device Description : SecLoc, INTRO21Gx2.75

Device Class :

Duns Number: 044611812

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 500

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