Avalon Aire AA-13
GUDID 00850014574000
Avalon Aire Chinstrap
PEPPER MEDICAL INC.
CPAP/BPAP face mask, single-use| Primary Device ID | 00850014574000 |
| NIH Device Record Key | 5fbf64a6-3a97-4f0f-a51c-b7f9592e3c04 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Avalon Aire |
| Version Model Number | AA-13 |
| Catalog Number | AA-13 |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 484-653-5473 |
| gschuster@peppermedical.com | |
| Phone | 484-653-5473 |
| gschuster@peppermedical.com | |
| Phone | 484-653-5473 |
| gschuster@peppermedical.com | |
| Phone | 484-653-5473 |
| gschuster@peppermedical.com | |
| Phone | 484-653-5473 |
| gschuster@peppermedical.com | |
| Phone | 484-653-5473 |
| gschuster@peppermedical.com | |
| Phone | 484-653-5473 |
| gschuster@peppermedical.com | |
| Phone | 484-653-5473 |
| gschuster@peppermedical.com | |
| Phone | 484-653-5473 |
| gschuster@peppermedical.com | |
| Phone | 484-653-5473 |
| gschuster@peppermedical.com | |
| Phone | 484-653-5473 |
| gschuster@peppermedical.com | |
| Phone | 484-653-5473 |
| gschuster@peppermedical.com | |
| Phone | 484-653-5473 |
| gschuster@peppermedical.com | |
| Phone | 484-653-5473 |
| gschuster@peppermedical.com | |
| Phone | 484-653-5473 |
| gschuster@peppermedical.com | |
| Phone | 484-653-5473 |
| gschuster@peppermedical.com | |
| Phone | 484-653-5473 |
| gschuster@peppermedical.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850014574000 [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 | 2023-06-16 |
| Device Publish Date | 2023-06-08 |
Devices Manufactured by PEPPER MEDICAL INC.
| 10850014574830 - Pepper Medical Closed Suction | 2025-09-23 Closed Suction Catheter, 12 French |
| 10850014574861 - Pepper Medical Closed Suction | 2025-09-23 Closed Suction Catheter, 6 French |
| 10850014574885 - Pepper Medical Closed Suction | 2025-09-23 Closed Suction Catheter, 8 French |
| 10850014574908 - Pepper Medical Closed Suction | 2025-09-23 Closed Suction Catheter, 12 French |
| 10850014575066 - Pepper Medical Closed Suction | 2025-09-23 Closed Suction Catheter, 16 French |
| 10850014574823 - Pepper Medical Closed Suction | 2025-09-19 Closed Suction Catheter, 14 French |
| 10850014574946 - Pepper Medical Closed Suction | 2025-09-19 Closed Suction Catheter, 8 French |
| 10850014574960 - Pepper Medical Closed Suction | 2025-09-19 Closed Suction Catheter, 10 French |
Trademark Results [Avalon Aire]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AVALON AIRE 87006064 5049890 Live/Registered |
Pepper Medical, Inc 2016-04-19 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.