Aerosure 1474
GUDID 10858058005044
ACTEGY LIMITED
Respiratory muscle training mask Respiratory muscle training mask Respiratory muscle training mask Respiratory muscle training mask Respiratory muscle training mask Respiratory muscle training mask Respiratory muscle training mask Respiratory muscle training mask Respiratory muscle training mask Respiratory muscle training mask Respiratory muscle training mask Respiratory muscle training mask Respiratory muscle training mask Respiratory muscle training mask Respiratory muscle training mask 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 |
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