Avalon Aire Nasal Pillow System AA-02

GUDID 10850014574755

Avalon Aire Nasal Pillow System

PEPPER MEDICAL INC.

CPAP/BPAP nasal mask, reusable

• Primary Device ID: 10850014574755
• NIH Device Record Key: 0e636da5-b65e-45b3-9a24-11da241cd9ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avalon Aire Nasal Pillow System
• Version Model Number: AA-02
• Catalog Number: AA-02
• Company DUNS: 622637098
• Company Name: PEPPER MEDICAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)647-0172
• Email: gschuster@peppermedical.com
• Phone: +1(800)647-0172
• Email: gschuster@peppermedical.com
• Phone: +1(800)647-0172
• Email: gschuster@peppermedical.com
• Phone: +1(800)647-0172
• Email: gschuster@peppermedical.com
• Phone: +1(800)647-0172
• Email: gschuster@peppermedical.com
• Phone: +1(800)647-0172
• Email: gschuster@peppermedical.com
• Phone: +1(800)647-0172
• Email: gschuster@peppermedical.com
• Phone: +1(800)647-0172
• Email: gschuster@peppermedical.com
• Phone: +1(800)647-0172
• Email: gschuster@peppermedical.com
• Phone: +1(800)647-0172
• Email: gschuster@peppermedical.com
• Phone: +1(800)647-0172
• Email: gschuster@peppermedical.com
• Phone: +1(800)647-0172
• Email: gschuster@peppermedical.com
• Phone: +1(800)647-0172
• Email: gschuster@peppermedical.com
• Phone: +1(800)647-0172
• Email: gschuster@peppermedical.com
• Phone: +1(800)647-0172
• Email: gschuster@peppermedical.com
• Phone: +1(800)647-0172
• Email: gschuster@peppermedical.com
• Phone: +1(800)647-0172
• Email: gschuster@peppermedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10850014574755 [Primary]

FDA Product Code

• BTK: STRAP, HEAD, GAS MASK

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: 2023-11-02
• Device Publish Date: 2023-10-25

Devices Manufactured by PEPPER MEDICAL INC.

• 00850014574208 - Foley Loc: 2024-08-02 Multi Tube Holder
• 00850014574017 - Trach Tie: 2023-11-08 Adult Trach Tube Holder
• 00850014574024 - Trach Tie: 2023-11-08 Adult Trach Tube Holder
• 00850014574055 - Pedi Tie: 2023-11-08 Pedi Trach Tube Holder
• 00850014574062 - Vent Tie: 2023-11-08 Adult Trach Tube Holder with Vent Anti-Disconnnect Device
• 00850014574086 - Vent Tie: 2023-11-08 Adult Trach Tube Holder with Vent Anti-Disconnnect Device
• 00850014574093 - Vent Tie: 2023-11-08 Adult Trach Tube Holder with Vent Anti-Disconnnect Device
• 00850014574123 - Trach Tie: 2023-11-08 Adult Trach Tube Holder