AVACEN
GUDID 00862800000389
The POP-ON/POP-OFF cuff is for replacement part on Gen 3 AVACEN products (HOME XL and PRO+).
AVACEN MEDICAL, INC
Electric pad localized-body heating system| Primary Device ID | 00862800000389 |
| NIH Device Record Key | af111749-44c8-4774-a1a0-0c2863858fa4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AVACEN |
| Version Model Number | POP-ON/POP-OFF CUFF |
| Company DUNS | 832744754 |
| Company Name | AVACEN MEDICAL, INC |
| 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 | false |
| 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 | true |
Customer Support Contacts
| Phone | 888-428-2239 |
| support@avacen.com | |
| Phone | 888-428-2239 |
| support@avacen.com | |
| Phone | 888-428-2239 |
| support@avacen.com | |
| Phone | 888-428-2239 |
| support@avacen.com | |
| Phone | 888-428-2239 |
| support@avacen.com | |
| Phone | 888-428-2239 |
| support@avacen.com | |
| Phone | 888-428-2239 |
| support@avacen.com | |
| Phone | 888-428-2239 |
| support@avacen.com | |
| Phone | 888-428-2239 |
| support@avacen.com | |
| Phone | 888-428-2239 |
| support@avacen.com | |
| Phone | 888-428-2239 |
| support@avacen.com | |
| Phone | 888-428-2239 |
| support@avacen.com | |
| Phone | 888-428-2239 |
| support@avacen.com | |
| Phone | 888-428-2239 |
| support@avacen.com | |
| Phone | 888-428-2239 |
| support@avacen.com | |
| Phone | 888-428-2239 |
| support@avacen.com | |
| Phone | 888-428-2239 |
| support@avacen.com |
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1600 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00862800000389 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133981
FDA Product Code
| IRT | Pad, Heating, Powered |
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 | 2023-03-20 |
| Device Publish Date | 2023-03-10 |
On-Brand Devices [AVACEN]
| 00862800000334 | 25-pack Mitts |
| 00862800000327 | 100-pack Mitts |
| 00862800000310 | Vacuum Chamber Insert (VCI) |
| 00862800000303 | The AVACEN 100 consists of a control panel, temperature-controlled raised thermal transfer pad, |
| 00862800000358 | The AVACEN PRO consists of a control panel, temperature-controlled raised thermal transfer pad, |
| 00862800000365 | The AVACEN PRO+ consists of a control panel, temperature controlled raised thermal transfer pad, |
| 00862800000396 | The AVACEN HOME XL consists of a control panel, temperature controlled raised thermal transfer p |
| 00862800000389 | The POP-ON/POP-OFF cuff is for replacement part on Gen 3 AVACEN products (HOME XL and PRO+). |
| 00862800000372 | The AVACEN HOME XL consists of a control panel, temperature controlled raised thermal transfer p |
| 00862800000341 | The AVACEN HOME+ consists of a control panel, temperature controlled raised thermal transfer pad |
Trademark Results [AVACEN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AVACEN 90606711 not registered Live/Pending |
Avacen 2021-03-26 |
 AVACEN 85333252 4083448 Dead/Cancelled |
AVACEN, INC. 2011-05-29 |
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