| Primary Device ID | 00869937000053 |
| NIH Device Record Key | 344523ed-228b-44b5-9e99-62592ce05cfc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ArroAir Max & Deluxe |
| Version Model Number | P-108060 |
| Company DUNS | 078585060 |
| Company Name | ARROWHEAD HEALTHCARE SUPPLY, LLC |
| 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 | false |
| Serial Number | true |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00869937000053 [Primary] |
| FNM | Mattress, Air Flotation, Alternating Pressure |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-22 |
| 00852685007009 - ArroAir DigiMax 8 LPM pump | 2018-03-29 ArroAir DigiMax 8 LPM pump |
| 00852685007016 - ArroAir Deluxe LAL/AP Mattress w/ DigiMax Pump | 2018-03-29 ArroAir Deluxe LAL/AP Mattress w/ DigiMax Pump |
| 00852685007023 - ArroAir Max Pump Only | 2018-03-29 ArroAir Max Pump Only |
| 00852685007030 - ArroAir Premier LAL/AP Mattress w/ DigiMax Pump | 2018-03-29 ArroAir Premier LAL/AP Mattress w/ DigiMax Pump |
| 10869937000029 - ArroAir Elite | 2018-03-29 ArroAir Elite Alternating Pressure Mattress Overlay system |
| 10869937000036 - ArroTemp Infrared Thermometer | 2018-03-29 ArroTemp Infrared non-contact Thermometer |
| 00869937000046 - ArroAir Max & Essential | 2018-03-29 ArroAir Max & Essential LAL/AP Mattress System, 8” Air Cells Only |
| 00869937000053 - ArroAir Max & Deluxe | 2018-03-29ArroAir Max & Deluxe LAL/AP Mattress System, 5” Air Cells with 3" Foam Cells secondary support |
| 00869937000053 - ArroAir Max & Deluxe | 2018-03-29 ArroAir Max & Deluxe LAL/AP Mattress System, 5” Air Cells with 3" Foam Cells secondary support |