Aerosure 1474
GUDID 10858058005044
ACTEGY LIMITED
Respiratory muscle training mask| Primary Device ID | 10858058005044 |
| NIH Device Record Key | 046b462f-0cbb-49c6-a429-c8a44daaffdf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aerosure |
| Version Model Number | 3481AJ |
| Catalog Number | 1474 |
| Company DUNS | 735575941 |
| Company Name | ACTEGY LIMITED |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com | |
| Phone | 8772603114 |
| us.info@actegy.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0.4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0.4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0.4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0.4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0.4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0.4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0.4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0.4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0.4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0.4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0.4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0.4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0.4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0.4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0.4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0.4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858058005047 [Primary] |
| GS1 | 10858058005044 [Package] Contains: 00858058005047 Package: Outer carton [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K140772
FDA Product Code
| BWF | Spirometer, Therapeutic (Incentive) |
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 | 2021-05-12 |
| Device Publish Date | 2021-05-04 |
Devices Manufactured by ACTEGY LIMITED
| 10858058005228 - Revitive Medic Coach | 2022-02-07 Neuromuscular Electrical Stimulation Device |
| 10858058005044 - Aerosure | 2021-05-12 |
| 10858058005044 - Aerosure | 2021-05-12 |
| 05060217492130 - Revitive Electrode Body Pads | 2021-05-12 |
| 10858058005259 - Revitive ProHealth | 2021-01-29 Neuromuscular Electrical Stimulation Device |
| 10858058005235 - Revitive Medic | 2021-01-27 Neuromuscular Electrical Stimulation Device |
| 10858058005105 - Revitive Essential | 2020-10-02 Neuromuscular Electrical Stimulation Device |
| 10858058005181 - Revitive Medic Knee | 2020-10-02 Neuromuscular Electrical Stimulation Device |
| 05060217493588 - Revitive Arthritis Knee Pads | 2020-08-05 Revitive Arthritis Knee Pads |
Trademark Results [Aerosure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AEROSURE 86006950 not registered Dead/Abandoned |
Aerovox Corp. 2013-07-10 |
 AEROSURE 79120042 4492947 Live/Registered |
Actegy Limited 2012-05-29 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.