FDA UDI
In Commercial Distribution
🇺🇸 United States
HoverMatt PROS Air
DI: 00816299012989
·
Model: PROS2-HM-KIT
·
Hovertech International
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- HoverMatt PROS Air
- Primary DI
- 00816299012989
- Version / Model
- PROS2-HM-KIT
- Company Name
- Hovertech International
- Labeler DUNS
- 942139841
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-27
- Public Version
- 1
- Public Version Date
- 2026-03-09
- Public Version Status
- New
- Public Device Record Key
- 3988b35a-25e4-4565-a5d1-12ed1efa3324
Device Description
The HoverMatt® PROS™ (Patient Repositioning Off-Loading System) Air, is breathable and used to assist caregivers with patient positioning (including boosting and turning), lateral transfers, and proning using air.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRZ | Device, Patient Transfer, Powered | General Hospital | 880.6775 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65774 | Inflatable patient transfer sliding mattress, reusable | An inflatable device designed to: 1) support a recumbent patient on a bed or table; and 2) assist healthcare professionals in the physical movement and transfer of a patient (e.g., hospitalized, disabled, geriatric) from one place to another using sliding techniques. It includes patient straps, handles for transfer, air hose inlets, and requires a pump (not included) for inflation; it is not intended for patient lifting. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00816299012996 | GS1 | Case | 3 | In Commercial Distribution | |
| Primary | 00816299012989 | GS1 |