Halo

GUDID 20858743005035

Halo Closed Syringe Adaptor

J & J SOLUTIONS, INC.

Medication transfer set

• Primary Device ID: 20858743005035
• NIH Device Record Key: 8acbe460-bc2c-420b-b310-343f89572489
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Halo
• Version Model Number: CSA100
• Company DUNS: 827056123
• Company Name: J & J SOLUTIONS, INC.
• Device Count: 240
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-651-6832
• Email: support@corvidamedical.com
• Phone: 1-800-651-6832
• Email: support@corvidamedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858743005031 [Unit of Use]
GS1	20858743005035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150486

FDA Product Code

• ONB: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

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: 2016-09-24

On-Brand Devices [Halo]

• 20858743005066: 13mm Vial Converter
• 20858743005059: Halo Closed Bag Adaptor
• 20858743005042: Halo Closed Line Adaptor
• 20858743005035: Halo Closed Syringe Adaptor
• 20858743005028: Halo 13mm Closed Vial Adaptor
• 20858743005011: Halo 20mm Closed Vial Adaptor
• 20858743005004: Halo 28mm Closed Vial Adaptor