FDA UDI
In Commercial Distribution
🇺🇸 United States
Single Patient Use HoverMatt
DI: 00816299012170
·
Model: RGMT34FL-REG
·
Hovertech International
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Single Patient Use HoverMatt
- Primary DI
- 00816299012170
- Version / Model
- RGMT34FL-REG
- Catalog Number
- RGMT34FL-REG
- Company Name
- Hovertech International
- Labeler DUNS
- 942139841
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-16
- Public Version
- 1
- Public Version Date
- 2023-01-24
- Public Version Status
- New
- Public Device Record Key
- 8d355e9c-087e-4b51-84d3-7e236557c72b
Device Description
34" Single Patient Use Air Transfer Mattress: Regard(ROI)
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
- No
- 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 |
|---|---|---|---|---|
| 37160 | Patient transfer system, powered | A mains electricity (AC-powered) assembly of devices used to transfer a supine patient, typically from his/her bed or transport stretcher to an operating table or vice versa. It is usually installed in large operating room (OR) complexes and serves as a sluice providing demarkation between the OR staff and the ward staff/porters and related devices. It may be designed as a motorized belt that is wider than the length of the patient and that rotates around a moveable pick-up plate which feeds in under the patient, drawing him/her onto the belt and depositing him/her onto an adjacent surface. It is typically fully automated, requiring no human intervention other than to operate the controls. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816299012170 | GS1 | ||||
| Package | 00816299012125 | GS1 | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 1(800)471-2776
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 34 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 158 Degrees Fahrenheit