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.
| 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 |
Trademark Results [Avalon Aire]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AVALON AIRE 87006064 5049890 Live/Registered |
Pepper Medical, Inc 2016-04-19 |
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