FDA UDI
In Commercial Distribution
🇺🇸 United States
Q2 Roller Lateral Turning Device
DI: 00816299011678
·
Model: HTR-200-1Roller
·
Hovertech International
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Q2 Roller Lateral Turning Device
- Primary DI
- 00816299011678
- Version / Model
- HTR-200-1Roller
- Catalog Number
- HTR-200-1Roller
- Company Name
- Hovertech International
- Labeler DUNS
- 942139841
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-28
- Public Version
- 1
- Public Version Date
- 2024-09-05
- Public Version Status
- New
- Public Device Record Key
- 139ad5e1-8e7a-416f-94ed-211440dbc4c1
Device Description
Q2Roller w/ 5 pack of chux
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| FMR | Device, Transfer, Patient, Manual | General Hospital | 880.6785 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46148 | Patient transfer system, manual | A wheeled stretcher and a mechanism on which a patient can be placed so that the patient can be transferred with minimal disturbance (i.e., without changing horizontal body position, lifting, rolling, or dragging). The device typically includes a patient-transfer mechanism (e.g., mechanical, hydraulic) easy to operate by an attendant with minimal physical effort. It is used in hospitals and other healthcare facilities to reduce injuries to both patients and staff while transferring non-ambulatory, comatose, or neurologically-injured patients between beds, tables, and/or stretchers. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00816299011647 | GS1 | box | 5 | In Commercial Distribution | |
| Primary | 00816299011678 | GS1 |
Customer Contacts
- Phone
- 6106949600
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 44 | Inch |