Introducer Needle 5584180

GUDID 20801741045138

Introducer Needle 18 ga

Bard Access Systems, Inc.

Vascular catheter introduction needle

• Primary Device ID: 20801741045138
• NIH Device Record Key: 3837ba06-1c22-42cc-b3d8-f3af4943cb09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Introducer Needle
• Version Model Number: 5584180
• Catalog Number: 5584180
• Company DUNS: 044611812
• Company Name: Bard Access Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com

Device Dimensions

• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Needle Gauge: 18 Gauge
• Length: 70 Millimeter
• Needle Gauge: 18 Gauge
• Length: 70 Millimeter
• Needle Gauge: 18 Gauge
• Length: 70 Millimeter
• Needle Gauge: 18 Gauge
• Length: 70 Millimeter
• Needle Gauge: 18 Gauge
• Length: 70 Millimeter
• Needle Gauge: 18 Gauge
• Length: 70 Millimeter
• Needle Gauge: 18 Gauge
• Length: 70 Millimeter
• Needle Gauge: 18 Gauge
• Length: 70 Millimeter
• Needle Gauge: 18 Gauge
• Length: 70 Millimeter
• Needle Gauge: 18 Gauge
• Length: 70 Millimeter
• Needle Gauge: 18 Gauge
• Length: 70 Millimeter
• Needle Gauge: 18 Gauge
• Length: 70 Millimeter
• Needle Gauge: 18 Gauge
• Length: 70 Millimeter
• Needle Gauge: 18 Gauge
• Length: 70 Millimeter
• Needle Gauge: 18 Gauge
• Length: 70 Millimeter
• Needle Gauge: 18 Gauge
• Length: 70 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741045134 [Primary]
GS1	10801741045131 [Package]; Contains: 00801741045134; Package: CA [10 Units]; In Commercial Distribution
GS1	20801741045138 [Package]; Contains: 10801741045131; Package: BX [36 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082580

FDA Product Code

• DYB: INTRODUCER, CATHETER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-02-22

On-Brand Devices [Introducer Needle]

• 20801741045138: Introducer Needle 18 ga
• 10801741041829: SecLoc,INTRO 21x2.75 WSF
• 10801741041812: SecLc,INTR 21Gx2.75 ST
• 20801741041802: SecLoc, INTRO 21Gx2
• 10801741041799: SecLoc, INTRO 21Gx2
• 10801741041744: SecLoc, INTRO18Gx2.75
• 20801741041734: SecLoc,INTRO 18Gx2.75ST
• 20801741041727: SecLoc,INTRO 21Gx2.75
• 10801741041713: SecLoc,INTRO 21Gx2.75
• 10801741041676: SecLoc,INTRO18Gx3.5 W SF
• 10801741041652: SecLoc,INTRO 18Gx2.75 W
• 20801741041642: SecureLoc 18G x 2.75 inch
• 10801741087780: SecureLoc 21G x 2.75 inch
• 10801741087773: SecLoc,INTRO 18Gx3.5 ST
• 10801741075398: SecLoc, INTRO 21Gx2.75
• 10801741075381: SecLoc, INTRO21Gx2.75
• 10801741075343: SecureLoc 18G x 2.75 inch
• 10801741075336: SecLoc,INTRO 18Gx2.75