Aspiration and Flush Assembly AFA-LB

GUDID H862AFALB2

ASPIRATION FLUSH ADAPTER – LARGE BORE SYSTEM

URESIL, LLC

General-purpose catheter connector, sterile Luer/non-ISO80369-standardized linear connector, single-use Luer/non-ISO80369-standardized linear connector, single-use Luer/non-ISO80369-standardized linear connector, single-use Luer/non-ISO80369-standardized linear connector, single-use Luer/non-ISO80369-standardized linear connector, single-use Luer/non-ISO80369-standardized linear connector, single-use

• Primary Device ID: H862AFALB2
• NIH Device Record Key: 7ce9818c-5798-4be0-9532-99a3eb87eccf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aspiration and Flush Assembly
• Version Model Number: AFA-LB
• Catalog Number: AFA-LB
• Company DUNS: 192559557
• Company Name: URESIL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H862AFALB0 [Primary]
HIBCC	H862AFALB1 [Package]; Contains: H862AFALB0; Package: Dispenser [5 Units]; In Commercial Distribution
HIBCC	H862AFALB2 [Package]; Contains: H862AFALB1; Package: Shipper [5 Units]; In Commercial Distribution

FDA Product Code

• GBO: Catheter, Nephrostomy, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-22
• Device Publish Date: 2016-08-24

On-Brand Devices [Aspiration and Flush Assembly]

• H862AFA20P2: ASPIRATION FLUSH ADAPTER – LARGE BORE SYSTEM WITH FUNNEL
• H862UFALL2: Universal Funnel Adapter-Luer Lock
• H862DFALL2: ASPIRATION FLUSH ADAPTER – DOUBLE CLAMP
• H862AFALL2: ASPIRATION FLUSH ADAPTER – LUER LOCK SYSTEM
• H862AFALB2: ASPIRATION FLUSH ADAPTER – LARGE BORE SYSTEM
• 20817640020817: Universal Funnel Adapter-Luer Lock
• 10817640020209: ASPIRATION FLUSH ADAPTER – DOUBLE CLAMP
• 10817640020117: ASPIRATION FLUSH ADAPTER – LUER LOCK SYSTEM
• 10817640020100: ASPIRATION FLUSH ADAPTER – LARGE BORE SYSTEM