BiWaze Clear Dual Lumen Circuit With Face Mask - Adult Small BK289

GUDID 08500501360105

BiWaze Clear Dual Lumen Circuit With Face Mask - Adult Small

Abmrc LLC

Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable

• Primary Device ID: 08500501360105
• NIH Device Record Key: 80d036f7-0a41-43b1-b60e-8b89baa96683
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BiWaze Clear Dual Lumen Circuit With Face Mask - Adult Small
• Version Model Number: BK289
• Catalog Number: BK289
• Company DUNS: 033900786
• Company Name: Abmrc LLC
• 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: true
• 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: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08500501360105 [Primary]

FDA Product Code

• NHJ: Device, Positive Pressure Breathing, Intermittent

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-02
• Device Publish Date: 2023-07-25

Devices Manufactured by Abmrc LLC

• 08500501360013 - BiWaze Cough Dual Lumen Circuit With Mouthpiece: 2024-04-09 BiWaze Cough Dual Lumen Circuit With Mouthpiece
• 08500501360020 - BiWaze Cough Dual Lumen Circuit With Trach Adapter: 2024-04-09 BiWaze Cough Dual Lumen Circuit With Trach Adapter
• 08500501360037 - BiWaze Cough Dual Lumen Circuit With Face Mask - Child: 2024-04-09 BiWaze Cough Dual Lumen Circuit With Face Mask - Child
• 08500501360044 - BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Small: 2024-04-09 BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Small
• 08500501360051 - BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Medium: 2024-04-09 BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Medium
• 08500501360068 - BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Large: 2024-04-09 BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Large
• 08500501360075 - BiWaze Clear Dual Lumen Circuit With Mouthpiece: 2023-08-02 BiWaze Clear Dual Lumen Circuit With Mouthpiece
• 08500501360082 - BiWaze Clear Dual Lumen Circuit With Trach Adapter: 2023-08-02 BiWaze Clear Dual Lumen Circuit With Trach Adapter