HYDROAIRE
- Primary DI
- B2844200002HU1
- Brand
- HYDROAIRE
- Company
- AURORA MANUFACTURING, LLC
- Model
- 3000
- Catalog number
- 4200002HU
- Device description
- HOME USE
- Published
- 2017-02-17
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Product Codes#
| Code | Name |
|---|---|
| INX | Bed, Air Fluidized |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| INX | Bed, Air Fluidized | Physical Medicine | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| B2844200002HU1 | Primary | HIBCC | 0 |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 606232200
- Device count
- 1
- Premarket exempt
- true
- Serial number
- true
- Manufacturing date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| B2844200002INST1 | HYDROAIRE | 3000 | 4200002INST | 2017-02-17 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| B627AF10000 | Resurg Air Fluidized Therapy System | Auxilium Medical Inc. | INX | 2026-11-01 |
| 08720387388004 | AFCS PEARLS™ Control unit | Synergie Nederland B.V. | INX | 2021-08-20 |
| 08720387388011 | AFCS PEARLS™ Bed unit | Synergie Nederland B.V. | INX | 2021-08-20 |
| 08720387388028 | AFCS PEARLS™ Extension Hose | Synergie Nederland B.V. | INX | 2021-08-20 |
| 08720387388035 | AFCS PEARLS™ Air filter | Synergie Nederland B.V. | INX | 2021-08-20 |
| 08720387388042 | AFCS PEARLS™ Filter sheet large multifilament | Synergie Nederland B.V. | INX | 2021-08-20 |
| 08720387388059 | AFCS PEARLS™ Filter sheet small multifilament | Synergie Nederland B.V. | INX | 2021-08-20 |
| 08720387388066 | AFCS PEARLS™ Filter sheet large monofilament | Synergie Nederland B.V. | INX | 2021-08-20 |
| 08720387388073 | AFCS PEARLS™ Filter sheet small monofilament | Synergie Nederland B.V. | INX | 2021-08-20 |
| 08720387388110 | AFCS PEARLS™ & SANDS™ Corner clamps | Synergie Nederland B.V. | INX | 2021-08-20 |
| 08720387388127 | AFCS PEARLS™ Control unit | Synergie Nederland B.V. | INX | 2021-08-20 |
| 08720387388134 | AFCS PEARLS™ Traction support pole | Synergie Nederland B.V. | INX | 2021-08-20 |
| 08720387388141 | AFCS PEARLS™ Backrest | Synergie Nederland B.V. | INX | 2021-08-20 |
| B2844200002INST1 | HYDROAIRE | AURORA MANUFACTURING, LLC | INX | 2017-02-17 |
| 00887761013834 | Envella™ Bed | HILL-ROM, INC. | INX | 2016-09-17 |
| 00887761996823 | Patient Helper | HILL-ROM, INC. | INX | 2016-09-17 |