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

INTRODUCER, CATHETER (DYB) (3) TUBE, GASTRO-ENTEROSTOMY (KGC) (3) TUBES, GASTROINTESTINAL (AND ACCESSORIES) (KNT) (3) DEVICE, INTRAVASCULAR CATHETER SECUREMENT (KMK) (1) Tape and bandage, adhesive (KGX) (1)

Premarket Exempt

No Yes

Clear

Introducer Needle - 10801741075398 Catalog Number : S03121-275W

Device Description : SecLoc, INTRO 21Gx2.75

Device Class :

Duns Number: 044611812

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 500

Securis - 10801741075466 Catalog Number : SECNS01

Device Description : SECURIS STABILIZATION DEVICE w/DFU, 1000 units, SECNS01

Device Class :

Duns Number: 044611812

Premarket Exempt : Yes

Product Code : KMK, KGX

Prescription Use : Yes

Device Count : 1000

Dual Port Feeding Adaptor - 10801741080880 Catalog Number : 000317

Device Description : 16 Fr Dual Port Feeding

Device Class :

Duns Number: 044611812

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 5

Dual Port Feeding Adaptor - 10801741080897 Catalog Number : 000318

Device Description : Dual Port Feeding

Device Class :

Duns Number: 044611812

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 5

Dual Port Feeding Adaptor - 10801741080934 Catalog Number : 000333

Device Description : Dual Port Feeding Adaptor

Device Class :

Duns Number: 044611812

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 5

Introducer Needle - 10801741087773 Catalog Number : S03118-350

Device Description : SecLoc,INTRO 18Gx3.5 ST

Device Class :

Duns Number: 044611812

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 500

Introducer Needle - 10801741087780 Catalog Number : S03521-275

Device Description : SecureLoc 21G x 2.75 inch

Device Class :

Duns Number: 044611812

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 500

Bard Button Replacement Gastrostomy Device - 10801741087827 Catalog Number : 000261

Device Description : Button Kit

Device Class : 2

Duns Number: 044611812

Premarket Exempt : No

Product Code : KGC

Prescription Use : Yes

Device Count : 1

Bard Button Replacement Gastrostomy Device - 10801741087834 Catalog Number : 000262

Device Description : Button Kit

Device Class : 2

Duns Number: 044611812

Premarket Exempt : No

Product Code : KGC

Prescription Use : Yes

Device Count : 1

Bard Button Replacement Gastrostomy Device - 10801741087841 Catalog Number : 000263

Device Description : Button Kit

Device Class : 2

Duns Number: 044611812

Premarket Exempt : No

Product Code : KGC

Prescription Use : Yes

Device Count : 1

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