| Primary Device ID | 00609953780016 |
| NIH Device Record Key | 615cd362-4471-4c5a-96f3-035bab2aa04e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Airisana |
| Version Model Number | ARSN--4880 |
| Company DUNS | 121788819 |
| Company Name | Encompass Group, L.L.C. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-284-4540 |
| compliance@encompassgroup.net | |
| Phone | 1-800-284-4540 |
| compliance@encompassgroup.net | |
| Phone | 1-800-284-4540 |
| compliance@encompassgroup.net | |
| Phone | 1-800-284-4540 |
| compliance@encompassgroup.net | |
| Phone | 1-800-284-4540 |
| compliance@encompassgroup.net | |
| Phone | 1-800-284-4540 |
| compliance@encompassgroup.net | |
| Phone | 1-800-284-4540 |
| compliance@encompassgroup.net | |
| Phone | 1-800-284-4540 |
| compliance@encompassgroup.net | |
| Phone | 1-800-284-4540 |
| compliance@encompassgroup.net | |
| Phone | 1-800-284-4540 |
| compliance@encompassgroup.net | |
| Phone | 1-800-284-4540 |
| compliance@encompassgroup.net | |
| Phone | 1-800-284-4540 |
| compliance@encompassgroup.net | |
| Phone | 1-800-284-4540 |
| compliance@encompassgroup.net | |
| Phone | 1-800-284-4540 |
| compliance@encompassgroup.net | |
| Phone | 1-800-284-4540 |
| compliance@encompassgroup.net | |
| Phone | 1-800-284-4540 |
| compliance@encompassgroup.net | |
| Phone | 1-800-284-4540 |
| compliance@encompassgroup.net |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00609953780016 [Primary] |
| IKZ | Bed, Patient Rotation, Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-05-05 |
| Device Publish Date | 2023-01-20 |
| 00609953780054 | AIRISANA THRPTC SYSTEM 48"X84" SURFACE AND UNIT SYSTEM, 48X84X9.25 |
| 00609953780016 | AIRISANA THRPTC SYSTEM 48"X80" SURFACE AND UNIT SYSTEM, 48X80X9.25 |
| 00609953780009 | AIRISANA THRPTC SYSTEM 42"X84" SURFACE AND UNIT SYSTEM, 42X84X9.25 |
| 00609953779737 | AIRISANA THRPTC SYSTEM 42"X80" SURFACE AND UNIT SYSTEM, 42X80X9.25 |
| 00609953779713 | AIRISANA THRPTC SYSTEM 36"X84" SURFACE AND UNIT SYSTEM, 36X84X9.25 |
| 00609953768076 | AIRISANA THRPTC SYSTEM 36"X80" SURFACE AND UNIT SYSTEM, 36X80X9.25 |
| 00609953767246 | AIRISANA SYS CONTROL UNIT MATTRESS REPLACEMENT CTRL AIRISANA SYS |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AIRISANA 88572159 not registered Live/Pending |
Encompass Group, LLC 2019-08-08 |