BiWaze Clear Dual Lumen Circuit With Face Mask - Child BK291

GUDID 08500501360099

BiWaze Clear Dual Lumen Circuit With Face Mask - Child

Abmrc LLC

Ventilator breathing circuit, reusable

• Primary Device ID: 08500501360099
• NIH Device Record Key: f338ce9b-4da6-411f-95a8-d2c286e60ad9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BiWaze Clear Dual Lumen Circuit With Face Mask - Child
• Version Model Number: BK291
• Catalog Number: BK291
• 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	08500501360099 [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